`[Federal Register Volume 89, Number 246 (Monday, December 23, 2024)]
[Rules and Regulations]
[Pages 104367-104393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30211]



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 Rules and Regulations
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  Federal Register / Vol. 89, No. 246 / Monday, December 23, 2024 / 
Rules and Regulations  

[[Page 104367]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Doc. No. AMS-NOP-22-0063]
RIN 0581-AE13


National Organic Program; Market Development for Mushrooms and 
Pet Food

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Final rule.

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SUMMARY: The United States Department of Agriculture (USDA) 
Agricultural Marketing Service (AMS) is amending the USDA organic 
regulations to clarify standards for organic mushrooms and organic pet 
food. The topics addressed by the rule include mushroom substrate 
composition and sourcing of mushroom spawn in organic mushroom 
production, composting requirements for organic mushroom production, 
composition and labeling requirements for organic pet food, and the use 
of certain synthetic substances, including taurine, in organic pet 
food.

DATES: 
    Effective date: This rule is effective February 21, 2025.
    Compliance date: Organic operations must comply with the 
requirements of this rule by February 22, 2027.
    For additional discussion, see section I.C. of this document.

FOR FURTHER INFORMATION CONTACT: Erin Healy, Director, Standards 
Division, National Organic Program. Telephone: 202-720-3252. Email: 
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. General Information
    A. Does this final rule apply to me?
    B. Summary of Provisions
    C. Implementation and Compliance Dates
II. Background
    A. Purpose and Need for the Rule
    B. National Organic Standards Board (NOSB) Recommendations on 
Mushrooms and Pet Food
    C. Community and Stakeholder Feedback
    D. Authority
III. Organic Mushroom Standard
    A. Mushroom Background
    B. Need for Organic Mushroom Standards
    C. Overview of Final Rule Policy and Responses to Comments
IV. Organic Pet Food Standard
    A. Pet Food Background
    B. Need for Organic Pet Food Standards
    C. Overview of Final Rule Policy and Responses to Comments
V. Regulatory Analyses
    A. Executive Orders 12866, 13563, 14094, and the Regulatory 
Flexibility Act
    B. Executive Order 12988
    C. Executive Order 13132
    D. Executive Order 13175
    E. Civil Rights Impact Analysis
    F. Paperwork Reduction Act

I. General Information

A. Does this final rule apply to me?

    You may be affected by this final rule if you are engaged in 
organic mushroom production, pet food handling, or related activities. 
Potentially affected entities may include, but are not limited to, the 
following:
     Organic mushroom producers (including organic spawn 
producers);
     Organic pet food manufacturers;
     Individuals or business entities that are considering 
organic certification for pet food or mushroom production (or related 
activities, such as spawn production);
     USDA-accredited certifying agents (or ``certifiers''), 
inspectors, and certification review personnel.
    This list is not exhaustive but identifies key entities that this 
rule may affect. Other types of entities may also be affected. To 
determine whether you or your business may be affected by this action, 
you should carefully examine the regulatory text and discussion below. 
If you have questions regarding the applicability of this rule to a 
particular entity, contact the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. Summary of Provisions

    Through the amendments in this final rule, AMS is establishing 
standards for organic mushroom production and pet food handling. The 
standards are discussed in detail in this document. In summary, the 
rule:
     Establishes definitions for mushroom, mushroom mycelium, 
mushroom spawn, mushroom spawn media, and mushroom substrate for the 
purposes of the USDA organic regulations.
     Clarifies that mushrooms are a type of crop and updates 
the definition of crops to include mushrooms.
     Creates a new section of the organic regulations titled 
``Mushroom Production Practice Standard,'' to describe standards 
related to the production of mushrooms, mushroom spawn, and products of 
mushroom production.
     Specifies allowed substances in organic mushroom spawn 
media and organic mushroom substrate.
     Requires that uncomposted plant materials used in mushroom 
substrate be organic when commercially available; requires that 
operations describe in their organic system plan the procedures and 
criteria used to search for organic materials and the recordkeeping 
system used to track purchases of nonorganic plant materials.
     Allows nonorganic wood materials in mushroom substrate and 
spawn media.
     Requires that operations use organic mushroom spawn when 
commercially available.
     Describes minimum requirements for compost used in 
mushroom substrate. (The requirements for compost used in other types 
of crop production (i.e., plants) are unchanged.)
     Establishes definitions for pet and pet food for the 
purposes of the USDA organic regulations and clarifies that pet food is 
distinct from livestock feed under these regulations.
     Clarifies the requirements for composition and labeling of 
organic pet food using the existing regulatory framework for processed 
organic products.
     Allows use of synthetic taurine (an amino acid) in organic 
pet food, as well as other vitamins and minerals that are approved by 
the Food and Drug Administration.

C. Implementation and Compliance Dates

    As described in the DATES section of this rule, this rule becomes 
effective on February 21, 2025. However, AMS is allowing an additional 
two (2) years for organic operations to comply with the requirements of 
the final rule. Organic

[[Page 104368]]

operations must comply with the final rule by February 22, 2027.
    The compliance date establishes the date by which organic 
operations must comply with the requirements. However, organic 
operations may choose to comply with the final rule prior to the 
compliance date. For example, pet food operations may use taurine in 
organic pet food starting on the effective date of the final rule.
    For a discussion of the public comments related to the rule's 
implementation and compliance dates, see ``Responses to Public Comments 
on Implementation Timeline'' sections below in III.C. for mushrooms and 
IV.C. for pet food.

II. Background

A. Purpose and Need for the Rule

    This final rule amends the USDA organic regulations to establish 
specific standards for organic mushroom production and organic pet food 
handling. The purpose of these amendments is to resolve uncertainty and 
inconsistency in how the organic regulations apply to these two 
products. Inconsistent certification and enforcement practices for 
organic mushrooms and pet food fail to meet one of the purposes of the 
Organic Foods Production Act (OFPA): to assure consumers that 
organically produced products meet a consistent standard (7 U.S.C. 
6501(2)). Based on market penetration data and feedback from 
stakeholders, AMS believes that creating more consistency in the market 
and ensuring regulatory certainty will create conditions for growth in 
these two markets and other latent markets that support them, such as 
the markets for mushroom substrate and organic slaughter by-products.
    Certifiers have been using the organic crop production standards to 
certify organic mushrooms; however, AMS believes new standards are 
necessary to adequately address unique aspects of mushroom production 
that differ significantly from plant production. Certifiers' attempts 
to interpret the existing crop standards for mushroom production are 
currently inconsistent, which may lead to producers inconsistently 
applying the standards to substrate, spawn, and compost for mushroom 
production.
    Similarly, the current organic regulations do not specifically 
address pet food. Producers and certifiers have been applying a 
combination of the handling standards for processed products and the 
organic livestock feed standards to certify organic pet food, but their 
practices were not uniform. Neither the handling standards nor the 
livestock standards are sufficient to address the range of ingredients 
and nutrients that are necessary for pets. For example, the livestock 
feed standards include allowances for many of the nutrients that are 
necessary for pets but prohibit common pet food ingredients, such as 
slaughter by-products (e.g., animal and poultry by-product meal, animal 
liver).
    This rule also addresses feedback from the organic industry, which 
has asked USDA to implement outstanding NOSB recommendations, including 
standards for these two product categories. Stakeholders encouraged AMS 
to prioritize rulemaking for additional practice standards, including 
standards for organic pet food and mushrooms, at the March 2022 virtual 
listening session hosted by AMS. The changes in this rule are based on 
NOSB recommendations for mushroom production and pet food handling in 
response to the organic industry's interest in further developing the 
organic standards for these markets.
    Market penetration data supports the idea that the organic mushroom 
and organic pet food markets have a reasonable expectation of growth if 
uncertainty and inconsistency are removed as barriers. Both markets 
currently lag behind their most-comparable organic sectors. In 2023, 
sales of organic produce accounted for a 15.2 percent share of all 
produce sales in the United States,\1\ but mushrooms sold as organic 
only accounted for 9.6 percent of all mushroom sales during the 2023-
2024 marketing year.\2\ Considering that the consumer experience of 
purchasing mushrooms is typically similar to purchasing fruits and 
vegetables (they are packaged similarly and found in the same section 
of the grocery store), it is reasonable to conclude that some external 
barrier is inhibiting the organic mushroom market. Similarly, organic 
pet food accounts for only 0.32 percent of all pet food sales. The 
closest organic category of comparison for organic pet food is organic 
non-food products, which includes other products humans do not eat 
(e.g., linen/clothing, supplements, and personal care products). All 
other non-food product types tracked by the Organic Trade Association 
have at least twice the market share of organic pet food, with the 
organic products accounting for between 0.76 percent to 3.3 percent of 
their total market sales.\3\
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    \1\ Organic Trade Association. (2024). Organic Industry Survey. 
p. 41.
    \2\ USDA, National Agricultural Statistics Service. (August 21, 
2024). ``Mushrooms.''
    \3\ Organic Trade Association. (2024). Organic Industry Survey. 
p. 69.
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    In conclusion, AMS believes that clear and consistent standards for 
organic mushrooms and pet food may create the conditions necessary for 
organic markets to develop. Regulatory certainty encourages investment 
in nascent markets; investment increases production capacity; and 
production enables market growth. Clear standards will promote growth 
in the development of these markets by increasing consistency in 
certification and enforcement and removing uncertainty as a regulatory 
barrier to production and certification. Additionally, growth in these 
markets is likely to ensure consistent demand for organic inputs in 
underdeveloped markets like organic meat and organic slaughter by-
products. Ensuring consistent standards across the organic industry 
also protects the integrity of the organic seal by building consumer 
trust in the label.
    AMS provides additional discussion of the need for organic mushroom 
and pet food standards in the respective sections below (see ``III.B. 
Need for Organic Mushroom Standards'' and ``IV.B. Need for Organic Pet 
Food Standards'').

B. National Organic Standards Board (NOSB) Recommendations on Mushrooms 
and Pet Food

    The NOSB is a Federal advisory committee established by OFPA (7 
U.S.C. 6518) to provide recommendations to USDA on the development of 
organic standards and regulations. NOSB recommendations are developed 
through a rigorous process involving technical information, stakeholder 
input through public comment, open meetings, and a decisive two-thirds 
majority vote of the Board. Although the Board cannot direct or bind 
USDA through its recommendations, USDA uses the NOSB recommendations to 
inform rulemaking, including this rulemaking.

[[Page 104369]]

    Several times in its history, the NOSB has recognized the unique 
production needs of organic mushrooms and pet food and recommended 
standards specific to each market. The Board recommended organic 
mushroom standards in April 1995 \4\ and again in October 2001.\5\ 
Subsequently, the NOSB made a recommendation on organic pet food 
standards in November 2008,\6\ and in April 2013, the NOSB recommended 
amending the National List of Allowed and Prohibited Substances (or 
``National List'') to include taurine for use in pet food.\7\ This 
final rule is AMS's first rulemaking action related to these 
recommendations. The NOSB recommendations are discussed below.
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    \4\ NOSB. (April 24-28, 1995). ``Final minutes of the National 
Organic Standards Board full board meeting.'' http://www.dairyprogramhearing.com/getfile32e532e5.pdf?dDocName=STELPRDC5057442.
    \5\ NOSB. (2001). ``NOSB Final Recommendation on Mushroom 
Practice Standards.'' https://www.ams.usda.gov/sites/default/files/media/Recommended%20Mushroom%20Standards.pdf.
    \6\ NOSB. (November 19, 2008). ``Formal Recommendation from NOSB 
to NOP: Organic Pet Food Standards.'' https://www.ams.usda.gov/sites/default/files/media/NOP%20Final%20Rec%20Pet%20Food.pdf.
    \7\ NOSB. (April 11, 2013). ``Formal Recommendation from NOSB to 
NOP: Petition to add Required Synthetic Amino Acids for Pet Food.'' 
https://www.ams.usda.gov/sites/default/files/media/NOP%20Livestock%20Final%20Rec%20Pet%20Food%20Amino%20Acid%20amended.pdf.
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NOSB Recommendations on Mushroom Production
    In 2001, the NOSB recommended standards to:
     Prevent contact between organically produced mushrooms or 
mushroom growth substrates and prohibited substances;
     Require the use of organic spawn when commercially 
available;
     Require organically produced agricultural materials in 
mushroom substrate; and
     Allow nonorganic wood materials (e.g., sawdust) in 
mushroom substrate if trees have not been treated with prohibited 
substances for three years prior to harvest and have not been treated 
with prohibited substances after harvest.
NOSB Recommendations on Pet Food
    In November 2008, the NOSB recommended that organic claims on pet 
food should be regulated under a combination of organic livestock feed 
standards and organic processed products labeling requirements.\8\ The 
NOSB recommended standards to:
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    \8\ NOSB. (November 19, 2008). ``Formal Recommendation from NOSB 
to NOP: Organic Pet Food Standards.'' https://www.ams.usda.gov/sites/default/files/media/NOP%20Final%20Rec%20Pet%20Food.pdf.
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     Clarify which animals the pet food requirements would 
apply to by defining ``pets'' in the regulations;
     Label organic pet food using a framework consistent with 
labeling for organic human food, allowing the ``organic'' claim that 
requires a minimum of 95 percent organic ingredients and the ``made 
with organic (specified ingredients or food group(s))'' claim that 
requires a minimum of 70 percent organic ingredients;
     Clarify that organic slaughter by-products can be a 
component of organic pet food; and
     Allow taurine for use in pet food by adding it to the 
National List of allowed synthetic substances.\9\
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    \9\ The 2008 recommendation listed taurine and other additives 
as ``materials for possible petition to the National List for use in 
Pet Food.'' In 2013, the NOSB passed a motion to specifically 
recommend listing taurine ``as a feed additive for use in pet food, 
only.'' See NOSB. (April 11, 2013). ``Formal Recommendation from 
NOSB to NOP: Petition to add Required Synthetic Amino Acids for Pet 
Food.'' https://www.ams.usda.gov/sites/default/files/media/NOP%20Livestock%20Final%20Rec%20Pet%20Food%20Amino%20Acid%20amended.pdf.
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    AMS used the NOSB recommendations to inform this rulemaking.

C. Community and Stakeholder Feedback

    When developing this Market Development rule, AMS considered 
industry and stakeholder requests for specific mushroom and pet food 
standards, in addition to the NOSB recommendations. In March 2022, the 
National Organic Program (NOP) hosted a public listening session to 
give stakeholders the opportunity to comment on NOP's rulemaking 
priorities.\10\ During the listening session, many stakeholders 
provided written and oral comment to ask AMS to prioritize rulemaking 
for products, including mushrooms and pet food, that are currently 
being certified without standards specific to their unique production 
categories. Several stakeholders specifically suggested developing 
mushroom standards and noted that existing crop standards, including 
compost requirements, were not suited for mushroom production. 
Similarly, some commenters discussed the importance of establishing 
consistent pet food standards, naming it as another product that is 
currently certified without specific standards.
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    \10\ USDA, NOP. (March 21, 2022). ``National Organic Program 
priorities listening session.'' https://www.ams.usda.gov/event/national-organic-program-priorities-listening-session.
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    AMS also engaged directly with mushroom experts, producers, and 
trade associations about organic mushroom production in developing the 
proposed rule. These discussions affirmed that, without specific 
standards, certifiers are not consistent in how they apply organic 
standards to mushroom production. Comments received during the public 
comment period for the proposed rule confirmed that certifiers 
interpret the existing standards in different ways. Through industry 
feedback and comments during the public comment period--submitted by a 
range of industry parties--AMS learned what aspects of mushroom 
production need specific standards to ensure consistent application 
across certifiers and producers. This includes requirements for 
compost, origin and composition of substrate materials used for growing 
mushrooms, and origin and composition of spawn.
    Discussions with experts in the pet food industry, conducted prior 
to publishing the proposed rule, revealed that the key challenge with 
labeling pet food as organic is uncertainty around the allowance of 
specific ingredients. For example, under the current organic 
regulation, it is unclear if pet food manufacturers may use meat (i.e., 
the edible part of animal muscle and organs) or slaughter by-products 
(i.e., the parts of an animal not typically consumed by humans, such as 
poultry by-product meal or animal liver) in organic pet food. It is 
also unclear whether some necessary synthetic ingredients in pet food, 
such as taurine, are allowed (for additional discussion, see ``Sec.  
205.605 National List--Description of Final Policy'' in section IV.C).
    Additionally, stakeholders have noted that allowing organic 
slaughter by-products in organic pet food will allow livestock 
producers and slaughter facilities to earn organic premiums for these 
organic slaughter by-products, which would otherwise be sold without a 
premium for use in nonorganic products. AMS estimates that this rule 
could ensure consistent demand for over 6 million pounds of organic 
slaughter by-products annually, which is likely to grow over time.\11\
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    \11\ Data from the Institute for Feed Education & Research 
indicates that approximately 23 percent of the ingredient weight in 
conventional pet food is animal by-product and meal. This estimate 
is then applied to the estimate for pounds of organic pet food as 
reported by the Organic Trade Association and current market prices. 
Institute for Feed Education & Research. (March 2020). ``Pet food 
production and ingredient analysis.'' Organic Trade Association. 
(2022). Organic Industry Survey. p. 56.
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    Overall, this rulemaking addresses a need identified by the NOSB, 
industry

[[Page 104370]]

stakeholders, and public comments on the proposed rule. AMS expects 
that the specific standards in this final rule will support the 
development of organic markets for organic mushrooms and pet food by 
reducing uncertainty among certifiers, consumers, producers, and 
manufacturers. A full discussion of public comments received on the 
proposed rule, and AMS's responses to comments, can be found in later 
sections.

D. Authority

    OFPA \12\ authorizes the USDA to promulgate regulations to 
establish an organic certification program for producers and handlers 
of agricultural products that have been produced using organic methods 
(7 U.S.C. 6503(a)). This rule establishes new production and 
certification standards for two categories of products that are 
currently certified but lack specific organic standards. In 
establishing these standards, this rule supports the three purposes of 
OFPA: ``(1) to establish national standards governing . . . organically 
produced products; (2) to assure consumers that organically produced 
products meet a consistent standard; and (3) to facilitate interstate 
commerce in . . . food that is organically produced'' (7 U.S.C. 6501).
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    \12\ The Organic Foods Production Act of 1990, 7 U.S.C. 6501-
6524, is the statute from which the Agricultural Marketing Service 
derives authority to administer the NOP, and authority to amend the 
regulations as described in this final rule. The text of the 
codified statute is available at: https://uscode.house.gov/view.xhtml?path=/prelim@title7/chapter94&edition=prelim.
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    This rule clarifies how producers and certifiers should apply 
organic regulations to mushroom and pet food production, which will 
assure consumers that the organic label on these products meets a 
consistent standard. The rule will also assure producers that they 
operate in a fair and competitive environment with clear rules that all 
must follow.
    USDA administers organic standards through the Agricultural 
Marketing Service (AMS) National Organic Program (NOP). Final 
regulations establishing the NOP and the USDA organic regulations were 
published on December 21, 2000 (65 FR 80548) \13\ and were first 
implemented on October 21, 2002.\14\ Through these regulations, AMS 
oversees national standards for the production, handling, labeling, and 
sale of organically produced agricultural products.
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    \13\ USDA, AMS. (December 21, 2000). ``National Organic 
Program.'' Final Rule. 65 FR 80548 (codified at 7 CFR part 205). 
https://www.federalregister.gov/documents/2000/12/21/00-32257/national-organic-program.
    \14\ USDA, AMS. (March 20, 2001). ``National Organic Program; 
Correction of the effective date under Congressional Review Act 
(CRA).'' Final Rule. 66 FR 15619. https://www.federalregister.gov/documents/2001/03/20/01-6836/national-organic-program-correction-of-the-effective-date-under-congressional-review-act-cra.
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III. Organic Mushroom Standard

A. Mushroom Background

Mushroom Biology and Production
    Mushrooms are the fleshy, spore-bearing, fruiting body of some 
species of fungus. Mushrooms are just a portion of the fungal organism, 
which is mostly composed of mycelium, a root-like network of fungal 
structures (hyphae). Commercially grown mushrooms are typically 
produced in a stepwise process that propagates (increases) mycelium to 
ultimately produce mushrooms.
    In commercial mushroom production, mycelium is added to media 
(``spawn media''), such as grains, wood materials, or minerals, that 
supports its initial development. The mycelium draws nutrients and 
energy from this media to support its growth. The mycelium-colonized 
media is called ``spawn.'' Spawn is then inoculated into larger volumes 
of substrate--a base composed of materials such as grains, wood 
materials, composted materials, and/or other agricultural materials--
where the mycelium develops further, growing throughout the substrate. 
Depending on the mushroom species, this stage of production may occur 
in open beds (common for Agaricus bisporus) or in blocks (common for 
specialty mushrooms), though other methods are also used. Producers can 
trigger fruiting (i.e., the formation of mushrooms) of the inoculated 
substrate by establishing the right environmental conditions for that 
variety--e.g., humidity, temperature, air, and light. Depending on the 
variety and production system, the inoculated substrate may continue to 
fruit after the first harvest, and producers may harvest multiple crops 
of mushrooms from one batch of inoculated substrate in a given 
production cycle. Once the production cycle is complete and all 
mushrooms are harvested, a new batch of spawn inoculated into a new 
batch of substrate is generally needed to produce more mushrooms.

[[Page 104371]]

[GRAPHIC] [TIFF OMITTED] TR23DE24.226

    Commercial mushroom production mostly occurs in controlled indoor 
environments where temperature and humidity can be controlled. However, 
mushroom production can also occur outdoors, either in managed 
conditions or by harvesting wild mushrooms. This final rule establishes 
new production standards for managed mushroom production, whether it 
occurs indoors or outdoors. It revises the definition of wild crop to 
include mushrooms, but it does not establish separate production 
standards for wild mushrooms. Producers who harvest wild mushrooms 
should continue to follow the wild crop harvesting practice standard at 
Sec.  205.207.
    In some cases, a producer may propagate mycelium but not harvest 
mushrooms. For example, some producers may only produce and sell spawn 
(colonized media) that other producers will use to inoculate substrate 
and produce mushrooms. In other cases, a producer may never aim to 
produce mushrooms (i.e., the fruiting bodies) but will instead produce 
mycelium biomass that is used in processed products for direct human 
consumption.
    This final rule specifies the production requirements for 
mushrooms, spawn, and mushroom products sold as organic. It does not 
alter the requirements related to processed fungi products. The final 
rule describes the existing crop production requirements that apply to 
mushroom producers, but, primarily, it specifies requirements for the 
spawn media, spawn, and substrate used in mushroom production. AMS is 
aware that some in the mushroom industry use the terms ``media'' and 
``substrate'' interchangeably. As defined in this final rule, mushroom 
spawn media is the initial base material that is colonized by mycelium 
to produce spawn, and mushroom substrate is the mid-stage base material 
that is used in larger volumes, inoculated by spawn, and on which 
mushroom fruiting occurs.
    The term ``mushroom production'' is used throughout the rule to 
collectively refer to the production of mushrooms, spawn, and other 
mushroom products, even if a producer is not harvesting or selling the 
fruiting bodies (mushrooms). For example, an organic spawn producer may 
not harvest mushrooms, but this final rule still applies to organic 
spawn producers.
The U.S. Mushroom Market
    In the 2023-2024 growing season (July 2023 to June 2024), the U.S. 
mushroom crop volume was 659 million pounds with sales of $1.09 
billion.\15\ The Agaricus bisporus species of mushrooms accounted for 
approximately 98 percent of the total sales volume and approximately 92 
percent of the total value.\16\ Agaricus includes white mushrooms 
(including common, button, and champignon varieties, among others) and 
brown mushrooms (including crimini/cremini, Swiss, Roman, Italian, and 
Portobello/Portabello/Portabella varieties, among others). Outside of 
the Agaricus varieties, there are a multitude of cultivated 
``specialty'' mushrooms, including shiitake, oyster, enoki, maitake, 
pompom, lion's mane, Reishi, and others. Specialty mushrooms include 
foraged (wild) mushrooms (e.g., chanterelles, morels) and mushrooms 
that are intentionally cultivated outdoors.
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    \15\ USDA, National Agricultural Statistics Service, 
Agricultural Statistics Board. (August 21, 2024). ``Mushrooms.'' 
https://downloads.usda.library.cornell.edu/usda-esmis/files/r781wg03d/9593wm52z/9306vq05c/mush0824.pdf.
    \16\ USDA, National Agricultural Statistics Service, 
Agricultural Statistics Board. (August 21, 2024). ``Mushrooms.'' 
https://downloads.usda.library.cornell.edu/usda-esmis/files/r781wg03d/9593wm52z/9306vq05c/mush0824.pdf.
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    Organic mushrooms lag behind the overall organic produce market in 
terms of market share. In 2023-2024, 9.6 percent of all mushrooms 
produced were sold as organic.\17\ The Organic Trade Association 
reports that organic produce they tracked had a higher market share, 
with 15.2 percent of all produce being sold as organic in 2023.\18\ 
Agaricus mushrooms accounted for approximately 83 percent of the total 
production volume of organic mushrooms; the remainder were specialty 
mushrooms.\19\
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    \17\ USDA, National Agricultural Statistics Service, 
Agricultural Statistics Board. (August 21, 2024). ``Mushrooms.'' 
https://downloads.usda.library.cornell.edu/usda-esmis/files/r781wg03d/9593wm52z/9306vq05c/mush0824.pdf.
    \18\ Organic Trade Association. 2024 Organic Industry Survey. p. 
41. https://ota.com/market-analysis/organic-industry-survey/organic-industry-survey.
    \19\ USDA, National Agricultural Statistics Service, 
Agricultural Statistics Board. (August 21, 2024). ``Mushrooms.'' 
https://downloads.usda.library.cornell.edu/usda-esmis/files/r781wg03d/9593wm52z/9306vq05c/mush0824.pdf.
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B. Need for Organic Mushroom Standards

    This final rule creates specific standards for organic mushroom

[[Page 104372]]

production to promote consistency, fair competition, and market growth. 
As of August 2024, at least 42 certifying agents certify 288 organic 
mushroom operations.\20\ The lack of mushroom-specific standards means 
there is significant variation in how these operations are certified. 
Some certifying agents require mushroom substrate components to be 
organic while others do not. Likewise, some certifying agents require 
spawn to be organic while others do not.
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    \20\ USDA, Organic Integrity Database. https://organic.ams.usda.gov/Integrity/Home. Advanced search features can be 
accessed at https://organic.ams.usda.gov/Integrity/Search. Certified 
mushroom producers may be found by narrowing a certified product 
search for ``mushrooms'' to operations with a certification status 
of ``certified'' and limiting results to the ``Crops'' scope. Output 
was manually cleaned to remove unrelated entries. Accessed August 
27, 2024.
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    This mushroom-specific rule is necessary because mushrooms and 
mushroom products involve unique production practices and inputs that 
are not addressed in the current organic standards. There are notable 
biological differences between mushrooms (which are fungi) and plants. 
Unlike plants, mushrooms do not photosynthesize to convert energy from 
light to process nutrients drawn from soil. Instead, they draw on the 
nutrition and energy found in the substrates on which they grow. The 
absence of mushroom-specific standards, their unique biological 
differences, and the resulting inconsistent enforcement, creates an 
uneven playing field for certified operations. For example, some 
operations may be required to source organic inputs, incurring 
additional expenses, whereas others are not. Unfair competition caused 
by different interpretations of the organic mushroom standards, as well 
as the possibility of future regulatory changes, may have reduced the 
willingness of businesses to invest in this sector.
    This rule aims to address these problems by developing one clear 
standard for organic mushroom production, ensuring consistency as 
directed by OFPA. Certifying agents will have clear rules to follow, 
and competition among operations will be more fair. This will give 
businesses greater confidence in the stability of the industry and 
encourage them to invest in organic mushroom growing operations and 
organic mushroom inputs.

C. Overview of Final Rule Policy and Responses to Comments

    This rule amends the USDA organic regulations (7 CFR part 205) to 
add new provisions for producing mushrooms, spawn, and other mushroom 
products (collectively ``mushroom production'') that are sold, labeled, 
or represented as organic. This action prescribes consistent standards 
for organic mushroom production, as detailed below.

  Table 1--Overview of Regulatory Changes To Establish Organic Mushroom
                          Production Standards
------------------------------------------------------------------------
    Section title       Type of action          Rulemaking action
------------------------------------------------------------------------
205.2................  Adds new terms..  Adds Mushroom; Mushroom
                                          mycelium; Mushroom spawn;
                                          Mushroom spawn media; Mushroom
                                          substrate.
205.2................  Revises existing  Modifies Compost; Crop; Wild
                        terms.            crop.
205.210..............  Adds new section  Adds mushroom production
                                          standards to Subpart C.
205.601..............  Revises language  Replaces the term ``plant''
                        at (i)-(j).       with the term ``crop''.
------------------------------------------------------------------------

Sec.  205.2 (Terms Defined)
Description of Final Policy
    The final rule amends Sec.  205.2 by adding five new terms: 
mushroom, mushroom mycelium, mushroom spawn, mushroom spawn media, and 
mushroom substrate. The rule also revises three existing terms: 
compost, crop, and wild crop. The additions and revisions are discussed 
below.
1. Compost
    The final rule revises the definition of compost to recognize that 
compost for mushroom production may be different than compost for plant 
production. The prior definition of ``compost'' included production 
requirements (e.g., time, temperature, and carbon-to-nitrogen ratio 
requirements) that are more applicable to plant production; however, 
compost for mushroom production is typically produced under different 
conditions. The final rule removes from the definition those specific 
compost production requirements, which duplicated the practice 
standards for other crop production already included in the organic 
regulations at Sec.  205.203(c)(2). The resulting definition of compost 
is more general, to encompass the production of compost for either 
plants or mushrooms. The amended definition also notes that compost may 
be used in mushroom production as a component of mushroom substrate.
    These revisions to the definition of the term compost are in no way 
meant to change existing requirements, policies, or guidance about the 
use of compost in organic plant production. Likewise, the revision is 
not intended to expand the definition of compost to include all 
agricultural inputs transformed by microorganisms, such as anaerobic 
digestate or manure. Terms for the various soil amendments and 
fertilizers used in organic production are well established by AMS and 
material review organizations and are not affected by this rule. AMS's 
intent is to remove the requirements embedded in the definition to 
account for the fact that compost for mushroom production is not 
necessarily produced in the same way that compost for plant production 
is produced.
    As noted above, the specific compost production requirements that 
AMS removed from the definition remain in the regulations at Sec.  
205.203(c)(2)--Soil fertility and crop nutrient management practice 
standard. This final rule does not change those requirements. Organic 
producers of crops other than mushrooms that use compost must comply 
with the requirements at Sec.  205.203(c)(2). Separately, this final 
rule adds mushroom-specific requirements for compost used in mushroom 
substrate at Sec.  205.210(c)(1), as described below in the section 
titled ``Mushroom production practice standard''.
    AMS is aware of ongoing discussions by the NOSB that may result in 
a recommendation to update the definition of compost. The changes in 
this final rule do not prevent or supersede future recommendations on 
this topic from the NOSB.
2. Crop and Wild Crop
    This final rule revises the terms crop and wild crop to include 
mushrooms. AMS includes mushrooms in these definitions to clarify that 
operations

[[Page 104373]]

may use certain crop and wild crop practice standards in subpart C of 7 
CFR part 205 to produce mushrooms.
3. Mushroom
    The final rule defines mushroom as the fleshy, spore-bearing 
fruiting body of a fungus, although the term ``mushroom production'' in 
this rule refers to production of mushrooms, spawn, and other mushroom 
products. The word ``mushroom'' is also used to qualify other terms 
(below) related to mushroom production.
4. Mushroom Mycelium
    AMS defines mushroom mycelium as a mass of branching, thread-like 
hyphae (fungal structures). Mushroom mycelium is the main, root-like, 
mass of a fungus, which can support formation of fruiting bodies 
(mushrooms).
5. Mushroom Spawn
    AMS defines mushroom spawn as mushroom spawn media that has been 
colonized by mycelium. Mushroom spawn can be used to inoculate mushroom 
substrate.
6. Mushroom Spawn Media
    AMS defines mushroom spawn media as the base material, such as 
grain, sawdust, other wood materials, vermiculite, or other minerals, 
used to make mushroom spawn. Mushroom spawn media, once colonized with 
mycelium, is defined separately as mushroom spawn by these regulations.
7. Mushroom Substrate
    AMS defines mushroom substrate as the base material (such as grain, 
wood materials, composted materials, and/or other agricultural 
materials) on which mushroom production occurs. Components of mushroom 
substrate can vary depending on the species to be cultivated. After 
mushroom spawn inoculates mushroom substrate, the mushroom substrate 
provides the energy and nutrients required for mycelium to flourish and 
produce mushrooms (although the definition of mushroom substrate does 
not depend on whether mushrooms are produced or not).
    AMS separately defines two types of ``base materials'' used in 
mushroom production: mushroom spawn media and mushroom substrate. For 
the purposes of organic regulation, the essential difference between 
them is that mushroom spawn media is the base material used to create 
mushroom spawn, while mushroom substrate is the base material that is 
inoculated by mushroom spawn to produce mushrooms. They are defined 
separately because the rule includes different requirements for 
mushroom spawn media and mushroom substrate. The composition 
requirements for mushroom spawn media and mushroom substrate are 
described at Sec. Sec.  205.210(d) and (c), respectively.
Changes From Proposed to Final Rule
    AMS made the following revisions to the proposed definitions in 
this final rule to clarify intent and meaning:
     AMS made minor changes to each definition related to 
mushroom production to clarify intent and meaning. AMS added the word 
``mushroom'' at the beginning of several terms so that the terms 
related to mushroom production appear together in Sec.  205.2.
     AMS removed the word ``edible'' from the definition of 
mushroom, as edibility is not unique to the mushroom's fruiting body 
(i.e., various parts of mushroom varieties may be edible), and 
edibility is not necessarily an attribute of all mushrooms. The word 
``edible'' is not required to describe the term mushroom.
Responses to Public Comment
    Public comments related to definitions for the mushroom standards 
and AMS's responses are discussed below.
Media/Substrate
    (Comment) Some commenters from the mushroom industry argued that 
some mushroom producers use the terms ``substrate'' and ``media'' 
interchangeably and that defining the terms separately is unnecessary 
and potentially confusing.
    (Response) AMS recognizes that these two terms can be used 
synonymously to refer to the ``base materials'' on which fungus grows. 
However, for the purposes of the organic regulations, AMS believes 
distinct definitions for mushroom spawn media and mushroom substrate 
are necessary to address requirements for distinct stages of organic 
mushroom production. The separate definitions allow AMS to regulate the 
inputs and management of mushroom spawn media and mushroom substrate 
differently in Sec.  205.210(c) and Sec.  205.210(d), respectively. To 
clarify the distinction in the regulations, AMS revised the definition 
of mushroom spawn media to more closely mirror the definition of 
mushroom substrate and more clearly highlight the essential difference 
between the terms as they are used in the final rule.
Compost
    (Comment) Some comments stated that removing the composting process 
from the definition of compost at Sec.  205.2 would make the definition 
too broad and incorporate other forms of microbial decomposition other 
than composting. Commenters noted that products such as sauerkraut, 
yogurt, beer, and manure digester products such as digestate and biogas 
could fall under the shortened definition.
    (Response) The revision of the term compost in the final rule is 
not intended to broaden the meaning of the term beyond the commonly 
accepted interpretation of the term. Outside this rule's allowance for 
compost in mushroom production, compost is currently allowed in organic 
crop production only as provided in Sec.  205.203(c)(2), which includes 
specific requirements that limit the types of processes that may be 
used. AMS chose not to leave the specific requirements in the 
definition for the term because of differences in requirements, 
formulation, and production of compost for mushroom production at Sec.  
205.210(c) and the requirements for other uses at Sec.  205.203.
    (Comment) Some comments requested that AMS amend the definition of 
compost to acknowledge that compost may be made with allowed synthetic 
compost feedstocks on the National List (Sec.  205.601). Other comments 
suggested that the definition be revised to allow compostable plastic 
materials, which is a subject currently on the NOSB work agenda.\21\ 
Several comments suggested that AMS adopt the definition of compost 
used by the American Association of Plant Food Control Officials 
(AAPFCO).
---------------------------------------------------------------------------

    \21\ USDA, NOP. (October 11, 2023). ``Work Agenda Request: 
Compost Production for Organic Agriculture.'' https://www.ams.usda.gov/sites/default/files/media/NOSBMemoCompostWorkAgenda23.pdf.
---------------------------------------------------------------------------

    (Response) AMS has not revised the compost definition to reference 
the synthetic compost feedstocks on the National List, adopt AAPFCO's 
definition, or include compostable plastics (bioplastics) as compost 
feedstocks. This final rule amended the definition of compost only as 
needed to accommodate the new mushroom production practice standards. 
The compost feedstocks that currently appear on the National List 
(e.g., newspaper) continue to be allowed under the regulations. AMS 
recognizes that the NOSB is currently working on recommendations 
related to the definition of compost and the requirements for compost 
in organic crop production in Sec.  205.203(c) (which are not changed 
by this rule). AMS has not received final recommendations from NOSB and 
is not making any

[[Page 104374]]

additional changes related to those topics in this rule at this time. 
This final rule does not conflict with or preclude future 
recommendations or rulemaking related to the current NOSB work agenda 
topics related to compost. If AMS seeks to revise the definition of 
compost or the compost requirements in the future, AMS will solicit 
public comments.
Mushroom
    (Comment) Some comments stated that the proposed definition of 
mushroom was too restrictive by referring only to the fruiting body. 
Comments noted that the term could be revised to include all parts of 
the organism to clarify that the regulations in the rule apply to the 
production of any part of the organism, such as mycelium, spores, and 
primordia (pinheads).
    (Response) AMS agrees that the standards at Sec.  205.210 can apply 
to production of other parts of the organism. However, we have not 
revised the definition of mushroom to include other parts of the 
organism in the final rule. The term mushroom refers specifically to 
the fruiting body, and this definition is similar to how the term is 
understood and interpreted broadly. The term ``mushroom production'' in 
this rule, however, can refer to production of mushrooms, spawn, and 
other mushroom products. Also see AMS's response to comments about 
requirements for mycelium biomass used as a direct ingredient for human 
consumption below in ``Sec.  205.210 (Mushroom production practice 
standards)'', ``Responses to Public Comment'', ``Mycelial Biomass 
Ingredients.''
    (Comment) Some comments suggested broadening the definitions and 
applicability of this rulemaking to include a broader spectrum of 
species in the Fungi Kingdom (e.g., yeast). Comments suggested that AMS 
describe the rule as a fungi production practice standard by revising 
``mushroom'' to ``fungi''. Comments from organic advocacy groups also 
argued that fungi should have its own scope of certification separate 
from crops, with fungi-specific production standards and specific 
sections of the National List for materials used in fungi production.
    (Response) AMS has not expanded the standards to apply to all 
fungi. Fungi is an extremely large and diverse taxonomic kingdom, of 
which mushrooms are only a small subset. Expanding the standards to 
other fungal products, such as yeasts, is beyond the scope of the rule. 
Developing new regulations for fungi other than mushrooms would require 
more input and assessment of impacts, as this was not included in the 
proposed rule.
    AMS also has not created a new scope of certification for mushrooms 
or fungi. ``Scope'' is a term typically used to describe one of the 
four areas of operation that a certifying agent may be accredited to 
certify. As defined in Sec.  205.2, the four areas of operation are 
crop, livestock, handling, and wild crop, or any combination thereof. 
These four scopes align with the types of Organic Plans listed in OFPA 
(7 U.S.C. 6513) and inform a range of other requirements and 
procedures, such as the determination of inspector qualifications and 
the issuance of certificates from the Organic Integrity Database. 
Creating a new scope of certification would require a range of 
regulatory amendments, as well as administrative and technological 
changes related to certification, accreditation, inspector 
qualifications, and certificates of organic operation. Furthermore, as 
with including fungi in the applicability of this rulemaking, the 
impacts of establishing a new scope of certification for fungi would 
require more input and assessment.
    AMS does not find that a new scope is necessary to accomplish the 
goals of this rule to provide consistent and clear standards for 
organic mushroom production that reflect the unique biology of 
mushrooms. AMS finds it appropriate to include mushrooms in the 
definition of crop and within the crops scope of certification. OFPA 
does not define or limit ``crops'' to include only organisms in the 
plant kingdom, and currently certified mushrooms are certified under 
the crop scope of the USDA organic regulations. Additionally, the 
organic regulations list mushroom inputs in the ``crops'' section of 
the National List of Allowed and Prohibited Substances (see 7 CFR 
205.601(o)). Across USDA programs, mushrooms are commonly considered a 
type of agricultural crop similar to other produce, vegetables, and 
specialty crops. Crops are a highly diverse group of agricultural 
products that are produced using similarly diverse production systems. 
The final rule acknowledges this diversity and clarifies how the 
organic regulations apply to the unique production requirements for 
mushrooms. The organic regulations continue to ensure certifying agents 
and inspectors have qualifications and expertise relevant to the scope 
and complexity of the operations (Sec.  205.501(a)(4)).
Wild Crop
    (Comment) One comment argued the lack of a definition for wild 
mushrooms could cause confusion since mushrooms are grown and/or 
harvested with a wide spectrum of production practices. Another comment 
requested that NOP develop standards for wild-grown mushrooms.
    (Response) The final rule amends the definition of wild crop to 
include mushrooms, thereby clarifying that wild mushrooms can be 
certified organic under the wild crop standards at Sec.  205.207. 
Amendments to the wild crop standards were not included in the proposed 
rule and are beyond the scope of this rulemaking.
Sec.  205.210 (Mushroom Production Practice Standard)
Description of Final Policy
    The final rule adds a new section (Sec.  205.210) to the USDA 
organic regulations to add provisions for producing mushrooms, spawn, 
and other mushroom products (collectively ``mushroom production'') that 
are sold, labeled, or represented as organic.
    Many of the existing production requirements in subpart C of the 
USDA organic regulations (7 CFR part 205) can be applied to mushroom 
production. However, mushroom production also relies on practices that 
are different from plant production practices. The final rule clarifies 
which of the existing crop production requirements apply to mushroom 
production and also adds requirements specific to mushroom production, 
as described below.
Applicability of Crop Standards in Subpart C--Sec.  205.210(a)
    AMS requires in Sec.  205.210(a) that organic mushroom operations 
follow most of the existing regulations governing crop production, 
including Sec. Sec.  205.200, 205.201, 205.202 as applicable, 
205.203(e), 205.206(a)(2)-(3), and 205.206(b)-(f). These sections cover 
general production requirements (Sec.  205.200); organic production and 
handling system plans (Sec.  205.201); land requirements (Sec.  
205.202); nutrient management prohibitions (Sec.  205.203(e)); and crop 
pest, weed, and disease management (Sec.  205.206). In addition, 
organic mushroom operations may follow the nutrient management 
practices in Sec.  205.203(d).
    Organic mushroom operations, like all other organic operations, 
must have an organic system plan that describes how the operation 
complies with applicable parts of the USDA organic regulations. 
However, because the methods used to produce mushrooms are different 
than

[[Page 104375]]

those to produce plants, the final rule clarifies that not all existing 
crop production requirements apply to organic mushroom production. 
Mushroom operations do not need to follow all the requirements in the 
soil fertility and crop nutrient management practice standard at Sec.  
205.203, the seeds and planting stock practice standard at Sec.  
205.204, or the crop rotation practice standard at Sec.  205.205. The 
final rule clarifies that mushroom producers are subject to the same 
nutrient management prohibitions as plant producers described in Sec.  
205.203(e) and may optionally follow the nutrient management practices 
in Sec.  205.203(d). Conversely, mushroom production does not involve 
seeds or planting stock, and mushrooms are not grown in rotations for 
fertility or disease suppression, so the final rule does not require 
producers to comply with Sec. Sec.  205.204-205.205.
Management of Mushroom Substrate and Mushroom Spawn Media--Sec.  
205.210(b)
    Paragraph 205.210(b) requires operations to manage mushroom 
substrate and mushroom spawn media in a way that avoids environmental 
contamination. The rule requires that mushroom substrate, mushroom 
spawn media, spent mushroom substrate, and spent mushroom spawn media 
be managed to avoid the contamination of any crops, mushroom spawn, 
mushroom substrate, soil, or water by pathogenic organisms, heavy 
metals, or residues of prohibited substances. This provision is similar 
to the requirement in Sec.  205.203(c) for other organic crop 
operations to prevent environmental contamination from materials 
applied to soil. Likewise, this requirement relates to and supports the 
requirement in Sec.  205.200 to maintain or improve the natural 
resources of the operation, including soil and water quality. Paragraph 
205.210(b) requires operations to manage materials in a way that avoids 
contamination throughout the entire mushroom production process, from 
mushroom spawn creation, to growing mushrooms, to disposal of spent 
substrate.
    Operations that only produce organic mushroom spawn and do not 
produce organic mushrooms are also subject to the provisions in 
paragraph (b). Mushroom spawn media is usually incorporated into 
mushroom substrate. In cases where a mushroom spawn producer disposes 
of spawn, the operation needs to dispose of spent mushroom spawn media 
in a manner that avoids contamination of crops, mushroom spawn, 
mushroom substrate, soil or water by pathogenic organisms, heavy 
metals, or residues of prohibited substances (Sec.  205.210(b)).
Composition of Mushroom Substrate--Sec.  205.210(c)
    Paragraph 205.210(c) describes the materials allowed in mushroom 
substrate. The paragraph addresses the acceptable use of five types of 
materials in mushroom substrate: composted plant and animal materials, 
uncomposted plant materials, wood materials, nonsynthetic substances, 
and synthetic substances.
    Paragraph 205.210(c)(1) describes requirements for composted plant 
and animal materials in mushroom substrate. This section details time, 
temperature, and composition requirements for composting plant and 
animal materials for use in mushroom production. The final rule 
requires that compost feedstock reach at least 131 [deg]F for at least 
three days during the composting process. AMS does not include a 
maximum temperature for mushroom compost production. The minimum 
temperature and duration requirements allow mushroom producers the 
flexibility to compost feedstocks at higher temperatures and/or for 
longer periods, if warranted. The compost must not be treated with any 
prohibited substances per the existing requirements at Sec.  
205.203(e)(1).
    AMS specifies in Sec.  205.210(c)(2) that uncomposted plant 
materials used in mushroom substrate must be organically produced when 
commercially available. The term commercially available is defined at 
Sec.  205.2. This requirement does not apply to plant materials that 
are used as compost feedstocks; it applies to plant materials added to 
mushroom substrate that do not undergo a composting step. Plant 
materials that are pasteurized or sterilized only, but not composted, 
are subject to the requirements of this paragraph, meaning they must be 
organic when commercially available. The requirement for organic plant 
materials also does not apply to wood materials (see Sec.  
205.210(c)(3)).
    Paragraph 205.210(c)(2) allows for nonorganically produced, 
uncomposted plant materials in mushroom substrate when a ``functionally 
equivalent'' organically produced input is not commercially available. 
Functional equivalence references a material's ability to fulfill an 
essential function in a system of organic production, as described in 
the definition of commercially available at Sec.  205.2. For the 
purposes of this exception, an ``essential function'' is a function of 
the same nature (e.g., the nutritional or structural characteristics 
the material provides in the mushroom substrate). When a functionally 
equivalent organic material is not commercially available, nonorganic 
plant materials may be used in substrate, except that prohibited 
substances must not be applied to any nonorganic plant material after 
harvest of the plant material.
    Paragraphs 205.210(c)(2)(i) through (iii) include specific 
requirements for operations that use nonorganically produced, 
uncomposted plant materials in mushroom substrate. Those operations 
must include additional elements in their organic system plan (OSP) as 
described below. The additional information is intended to provide 
certifiers with the information they require to determine whether 
functionally equivalent organically produced materials are commercially 
available for purposes of Sec.  205.210(c)(2).
    Paragraph 205.210(c)(2)(i) requires operations to describe in their 
OSP the procedures used to search for organic materials, as well as the 
records kept to document searches for organic materials. Procedures 
should demonstrate that operations contacted a sufficient number of 
sources to ascertain the commercial availability of organically 
produced plant materials. A producer must make a reasonable effort to 
search for organic materials from reasonable sources (i.e., those known 
to sell organic products). Procedures may include details about how an 
operation identifies potential sources (or suppliers) of organic 
materials and how the operation contacts those sources. The operation 
must also describe the types of records that are kept to document 
searches. This should include a description of the types of records 
kept and a description of the recordkeeping system, such as how the 
operation stores these records. Records may include, but are not 
limited to letters, email correspondence, phone logs, catalogs, 
searches of organic databases, receipts, receiving documents, invoices, 
and inventory control documents.
    Paragraph 205.210(c)(2)(ii) requires operations to describe in 
their OSP the criteria they use to evaluate if functionally equivalent 
organic materials are commercially available. Operations should 
describe how they determine the essential function (a function of the 
same nature, like the nutritional or structural characteristics) that 
they are not able to meet with organic plant materials, how they 
identify ``functionally equivalent'' organic plant materials to search 
for, and how they verify that ``functionally equivalent'' organic plant 
materials are

[[Page 104376]]

not commercially available to fulfill that essential function.
    Operations must establish an essential function to accurately 
verify if organic plant materials are commercially available. An 
operation may outline how they identify the essential function needed 
for a substrate material in their OSP. Additionally, an operation may 
identify essential functions they need in certain types of production 
in their OSP to ensure consistent searches.
    Operations should have criteria for identifying organic materials 
that would fulfill the essential function needed in their mushroom 
substrate in their OSP. This may include resources for determining 
functionally equivalent organic materials, methods for determining 
characteristics of materials, or testing procedures. In most cases, the 
direct organic analog(s) to the nonorganic plant material used should 
be included in the commercial availability search as a functionally 
equivalent material. Additionally, organic varieties of different plant 
materials may need to be considered in the search (e.g., organic 
soybean hulls may be reviewed as an alternative for conventional cotton 
seed hulls).
    An operation's OSP should include a description of how they 
evaluate if organic alternatives reviewed are not commercially 
available in the appropriate form, quality, or quantity to fulfill the 
essential function of the nonorganic plant material. Form 
considerations may include, but are not limited to method of harvest, 
processing, and preparation. Quality considerations may include, but 
are not limited to, the presence of residues, bacteria, fungus, or 
other micro-organisms, shelf life, and stability. Quantity 
considerations may include evidence that quantities are not available 
in sufficiently large or small amounts, given the scale of the 
operation. Price cannot be a consideration for the determination of 
commercial availability.
    Certifiers should verify that an operation has considered a 
sufficient number of plant materials in its search to fulfill an 
essential function in the mushroom substrate. Certifiers must use the 
definition of commercially available (see Sec.  205.2) and the 
requirements at Sec.  205.210(c)(2) to verify an operation's claim that 
organically produced plant materials necessary for mushroom production 
are not commercially available and should verify that a sufficient 
number of sources have been contacted.
    Paragraph 205.210(c)(2)(iii) requires that operations describe in 
their OSP the recordkeeping system used to document purchases of 
nonorganic plant materials (not including wood materials allowed under 
Sec.  205.210(c)(3)). The OSP must describe how the recordkeeping 
system can be used to summarize, by type, the amount of nonorganic 
plant materials purchased. Operations are obligated, generally, to 
maintain records and make them available for inspection (see Sec.  
205.103), but the additional information and summarization, in this 
case, will allow both certifiers and AMS to verify compliance. 
Summarized information will allow certifiers to assess the extent to 
which operations are utilizing nonorganic plant materials. 
Additionally, it will allow certifiers to compare an operation's use of 
nonorganic plant material year-to-year to identify trends or patterns. 
AMS could also request summarized information (via certifiers or from 
operations directly) to understand the practices around use of 
nonorganic plant materials in the industry, to target enforcement 
efforts, and/or inform future rulemaking priorities.
    Paragraph 205.210(c)(3) allows mushroom operations to use 
nonorganic wood materials (wood chips, sawdust, logs, or other 
materials derived from wood) in mushroom substrate. These materials 
must not be treated with prohibited substances after harvest of the 
tree or wood source. An operation does not need to search for organic 
forms of these wood materials (or document any search for organic 
forms), but it does need to verify that the wood materials were not 
treated with prohibited substances after harvest. The operation must 
keep records documenting the verification process.
    Paragraphs 205.210(c)(4) and (5), together with the amendment to 
the definition of crop in Sec.  205.2 to include mushrooms, 
specifically allow mushroom operations to use natural (nonsynthetic) 
substances and/or certain synthetic substances in mushroom substrate, 
in accordance with the National List of Allowed and Prohibited 
Substances (``National List'') for organic crop production. These 
provisions align with the requirements related to allowed and 
prohibited substances described at Sec.  205.105(a)-(b). Paragraph 
205.210(c)(4) allows the use of natural (nonsynthetic) substances in 
mushroom substrate. Examples include mined gypsum, chalk, and clay. 
However, operations must not use nonsynthetic substances prohibited for 
use in organic crop production in Sec.  205.602 of the National List.
    Paragraph 205.210(c)(5) permits mushroom producers to use certain 
synthetic substances that are included in the National List at Sec.  
205.601 as ``allowed'' for organic crop production. For example, 
microcrystalline cheesewax listed at Sec.  205.601(o)(1) may be used as 
a production aid in log-grown mushrooms. Again, Sec.  205.210(c)(5), 
together with the revision to the definition of crop in Sec.  205.2 to 
include mushrooms, clarifies that mushrooms are a type of crop and that 
the synthetic substances included on the National List at Sec.  205.601 
are allowed in organic mushroom production. (For additional discussion, 
see the section below titled ``Sec.  205.601 National List--Crop''). 
Any use of these allowed, synthetic substances in mushroom production 
must follow all applicable substance-specific restrictions from the 
National List, as well as Federal and State laws and regulations.
Requirements for Mushroom Spawn--Sec.  205.210(d)
    Paragraph 205.210(d) establishes requirements for spawn used in 
organic mushroom production. Producers must use organic spawn when 
commercially available, as defined at Sec.  205.2. When an equivalent 
organic spawn is not commercially available, a producer may use 
nonorganic spawn. An equivalent spawn could be a spawn of the same 
mushroom variety but on a different spawn media. For example, if 
millet-based spawn is equivalent to sorghum-based spawn and one is 
commercially available as organic, then the operation must use the 
organic spawn. Operations that use nonorganic spawn must keep records 
that demonstrate organic spawn was not commercially available. These 
records are necessary to comply with the recordkeeping requirements at 
Sec.  205.103. Records should demonstrate that the operation made an 
appropriate search for organic spawn and demonstrate that equivalent 
spawn was not available in the appropriate form, quality, or quantity.
    Paragraph 205.210(d)(1) describes the requirements for organic 
mushroom spawn. Agricultural materials in spawn media must be organic, 
except for wood materials, such as sawdust (Sec.  205.210(d)(1)(i)). If 
the mushroom spawn media contains wood materials, those materials must 
not be treated with prohibited substances after harvest, in accordance 
with Sec.  205.210(c)(3). The requirements do not allow for any 
nonorganic agricultural materials in organic mushroom spawn, except for 
wood materials.
    In addition to any agricultural materials, Sec.  205.210(d)(1)(ii) 
allows for organic spawn to contain natural (nonsynthetic) and 
synthetic substances that are allowed in organic production

[[Page 104377]]

as described in Sec.  205.210(c)(4) and (c)(5). Allowed natural 
substances are any nonsynthetic substances that do not appear on the 
National List of prohibited nonsynthetic substances (Sec.  205.602). 
Allowed synthetic substances are substances that appear on the National 
List of allowed synthetic substances (Sec.  205.601). Any use of these 
allowed synthetic substances in mushroom production must follow all 
applicable substance-specific restrictions included in the National 
List, as well as Federal and State laws and regulations. If a substance 
on the National List of allowed synthetic substances (Sec.  205.601) is 
restricted to a specific use(s) outside of mushroom production, it is 
not allowed in mushroom production. Additionally, Sec.  
205.210(d)(1)(ii) clarifies that compost as described in Sec.  
205.210(c)(1) is an allowed component of spawn media. Finally, Sec.  
205.210(d)(1)(iii) specifies that organic spawn must be under 
continuous organic management after the application of mycelium to 
mushroom spawn media.
    Paragraph 205.210(d)(2) includes requirements for operations that 
make their own spawn for their own mushroom production. In these cases, 
if a producer is unable to produce organic spawn that meets all the 
requirements at Sec.  205.210(d)(1), including (d)(1)(i) through (iii), 
they are still subject to a requirement to use organic agricultural 
materials when commercially available (except for wood materials, which 
do not need to be organic) in spawn media. Operations that use 
nonorganic materials must keep records that demonstrate organic 
materials were not commercially available. These records are necessary 
to comply with the recordkeeping requirements at Sec.  205.103. Records 
should demonstrate that the operation adequately searched for organic 
materials but could not find functionally equivalent materials in the 
required form, quality, or quantity.
    If a producer is not producing organic spawn that meets the 
requirements at Sec.  205.210(d)(1) but organic spawn of the same 
mushroom species/variety is commercially available, certifiers should 
place particular attention on evaluating an operation's claim that a 
suitable organic spawn cannot be made in compliance with Sec.  
205.210(d)(1). This paragraph does not allow for the sale of organic 
spawn that does not meet all requirements at Sec.  205.210(d)(1). In 
the case of an operation that produces organic spawn for sale as 
organic, all agricultural materials (except wood materials) in spawn 
media must be organic (Sec.  205.210(d)(1)(i)).
Changes From Proposed to Final Rule
    AMS made several changes to the regulatory text of the proposed 
rule when writing this final rule. Changes to the final rule are 
discussed below and are followed by specific topics and themes from 
public comment.
     Mushroom spawn and mushroom spawn media requirements 
(Sec.  205.210(d)) are now described in a paragraph separate from the 
mushroom substrate requirements (Sec.  205.210(c)).
     Wood materials are specifically noted as an allowed 
nonorganic agricultural material for mushroom substrate (Sec.  
205.210(c)(3)) and mushroom spawn media (Sec.  205.210(d)(1)(i)).
     Requirements are added for operations to describe in the 
organic system plan how they search for organic materials for mushroom 
substrate, evaluate available organic alternatives, and keep records of 
nonorganic materials used in mushroom substrate (Sec.  
205.210(c)(2)(i)-(iii)).
     Spawn production requirements are clarified for mushroom 
producers that make spawn on-site for their own organic mushroom 
production (Sec.  205.210(d)(2)).
Responses to Public Comment
    Below is a summary of comments received regarding organic mushroom 
production requirements and AMS's responses.
Commercial Availability for Mushroom Substrate
    (Comment) Some mushroom producers and trade groups asserted that it 
is essential to allow nonorganic materials for mushroom substrate when 
organic materials are not commercially available (also referred to as 
the ``commercial availability exception'' in this document). They said 
it would be impossible to source enough organic materials for 
substrate. Producers highlighted that substitution or variation of 
substrate materials can lead to detrimental yield drops and that 
organic materials are not consistently available year-round. It is 
unclear if some comments recognized that organic materials would not be 
required when composted, as some comments provided examples of inputs 
that are typically composted. A few certifiers and producers voiced 
support for a commercial availability exception but did not express 
broader concerns about sourcing.
    In contrast, many commenters voiced the desire to remove the 
proposed commercial availability exception to require only organic 
materials for uncomposted portions of substrate. These commenters 
included some smaller mushroom operations, certifiers, advocacy groups, 
and trade associations. Some argued that a commercial availability 
exception would inhibit growth of the market for organic inputs and 
result in minimal difference between organic and conventional 
mushrooms. Some commenters requested that organic inputs be required 
because mushrooms consume the substrate. Some of these commenters also 
argued that the commercial availability exception would create a cost 
disadvantage for small producers, who could not claim that organic 
inputs are unavailable in sufficient quantity as often as large 
producers. Comments noted that substrate composition is a key 
difference between organic and nonorganic mushrooms and argued that 
there should be substantive differences in production methods to 
justify any organic cost premium.
    (Response) AMS appreciates commenters' requests for the use of only 
organic substrate by all mushroom operations. We also recognize that 
the commercial availability exception for uncomposted plant inputs is a 
necessity in organic mushroom production for many organic mushroom 
operations. We remain uncertain if the industry could implement this 
rule and produce organic mushrooms using only organic inputs without 
loss of existing production. Therefore, AMS is maintaining commercial 
availability exceptions in the final rule, as proposed. However, we are 
adding requirements in the final rule for operations that use 
nonorganic uncomposted plant materials for mushroom substrate. To use 
these nonorganic materials for mushroom substrate, operations must 
describe, in their OSP, the methods and procedures used to search for 
organic materials; the criteria they use to evaluate if organic 
materials are commercially available, including comparable substrate 
materials; and the recordkeeping system used to document purchases of 
nonorganic materials.
    AMS is aware of commenters' concerns that large producers could be 
able to use the commercial availability exception more often compared 
to small producers. AMS understands that operations may need to utilize 
commercial availability exceptions differently based on a number of 
factors including geographic location, size, and type of mushroom 
grown. However, AMS believes this is a function of the flexibility of 
the commercial availability exception, and the additional requirements 
in the final rule will

[[Page 104378]]

increase fairness and consistency of implementation for both small and 
large producers.
    (Comment) Some commenters stated that commercial availability 
criteria should be strengthened, and that AMS should include specific 
requirements related to how operations must search for organic 
materials.
    (Response) In the final rule, AMS is requiring operations that use 
nonorganic uncomposted plant materials in mushroom substrate to 
describe in their organic system plan (OSP) how they searched for 
organic materials, evaluated if organic materials were commercially 
available, and documented these searches. The final rule requires that 
an operation must look at functionally similar organic alternatives 
(i.e., at materials that are comparable but not identical) to ensure 
that various organic alternatives are considered. The OSP requirements 
will, in turn, better equip certifiers to verify that producers are 
making sufficient and appropriate efforts to search for organic 
materials and only using nonorganic materials when organic options are 
not commercially available. Certifiers will be able to verify 
compliance by reviewing a producer's OSP and the associated records 
that document their searches and purchases.
Requirements for Wood Materials
    (Comment) The proposed rule stated that uncomposted plant materials 
(which could include wood products) must be organically produced when 
commercially available. Additionally, the proposed rule stated that any 
nonorganic plant materials must not be treated with prohibited 
substances after harvest. Some comments noted that it was not clear if 
AMS considered wood and wood-based materials (e.g., sawdust, wood 
chips) to be a type of ``plant material'' that is subject to the 
requirements for other plant materials. Comments requested that AMS 
clarify how wood materials are classified under the organic 
regulations; specifically, commenters asked if they should be 
considered a plant material (that must be organic unless not 
commercially available), or a nonsynthetic material that is not 
otherwise prohibited at Sec.  205.602 of the National List.
    (Response) The final rule clarifies the requirements for wood 
materials used in mushroom production. AMS revised the final rule to 
clearly and specifically allow for the use of nonorganic wood 
materials. Producers do not need to document that organic forms are not 
commercially available to use wood materials. Nonorganic wood materials 
must not be treated with prohibited materials after harvest.
    (Comment) In regard to the requirement that uncomposted plant 
materials be organic unless commercially unavailable, most commenters 
stated it would be almost impossible to source organic wood materials 
for mushroom substrate and mushroom spawn media and that there would 
need to be different requirements for wood inputs. A few commenters 
advocated for wood materials to be free from prohibited substances for 
3 years before harvest, rather than just free of prohibited treatments 
post-harvest, as proposed under the requirement for all uncomposted 
plant materials. In contrast, a few other comments noted that sawmills 
do not and could not track information on the three years of forest/
timber management prior to tree harvest. Overall, comments noted that 
organic wood-based products are not available and that requiring 
organic wood in mushroom products would pose an impossible barrier to 
organic production.
    (Response) AMS revised the final rule to clarify that wood 
materials used in mushroom substrate and mushroom spawn media do not 
need to be organic, but prohibited substances must not be applied after 
harvest. AMS considered comments that requested three years of 
management before harvest without the use of prohibited substances but 
has not adopted this requirement in the final rule. While a few 
operations and certifiers currently verify this condition, it does not 
seem to be a universal practice in the industry. Requiring 
documentation that wood materials have been free of prohibited 
materials for three years before harvest could be costly and require 
new documentation for entities outside the organic industry. 
Additionally, this requirement may limit the amount of sawdust, a key 
mushroom substrate input, that could be available for organic 
production, as wood from sawmills can be aggregated from many sources. 
This would require mushroom producers to gather information from many 
sources to confirm that trees were not treated with prohibited 
materials for the 3 years prior to harvest. In many cases, this 
information would not be available, as a sawmill would not likely be 
able to provide the necessary information. However, sawmills should 
have information about any treatments made after harvest and should be 
able to readily provide this information to mushroom producers.
Requirements for Compost
    (Comment) Some commenters expressed concern that altering the time, 
temperature, and turning requirements in mushroom compost could lead to 
food safety risks.
    (Response) AMS established composting requirements for mushrooms 
(Sec.  205.210(c)(1)) that accommodate special processes used to 
prepare substrate for mushroom production. These processes are 
presently used to produce mushrooms and include the minimum composting 
time and temperatures required for compost in other organic crop 
production. Compost must still meet other regulatory requirements for 
food safety, as applicable, like those related to the Food Safety 
Modernization Act, including the Product Safety Rule and the Pre-
Harvest Agricultural Water Final Rule.
    (Comment) Some commenters requested that AMS clarify if 
sterilization of substrate is considered equivalent to composting. Some 
commenters requested that AMS allow the use of nonorganic sterilized 
materials in organic mushroom production.
    (Response) The final rule allows nonorganic plant materials as 
compost feedstocks, but the sterilization process is different from 
composting. The composting process transforms starting materials 
(feedstocks) through biological processes; sterilization eradicates 
microbes and other life but does not transform starting material(s). 
Plant materials that are sterilized but never composted to meet the 
minimum requirements of Sec.  205.210(c)(1) may be used in accordance 
with Sec.  205.210(c)(2). This means they must be organic unless they 
are not commercially available, in which case nonorganic plant 
materials may be used. Wood-based components, such as sawdust, may be 
used in sterilized products without first seeking an organic form, in 
accordance with Sec.  205.210(c)(3).
    (Comment) Some commenters stated that the proposed requirements for 
compost in mushroom production, specifically the requirement that 
compost reach a temperature of at least 131 [deg]F for a minimum of 
three days, did not accurately reflect the entirety of the composting 
process used by mushroom producers (especially for Agaricus mushrooms). 
Specifically, these producers often use a two-phase composting process. 
Temperatures in the first phase typically go well above 131 [deg]F. In 
the second phase, temperatures are also brought higher than 131 [deg]F 
in a pasteurization step but

[[Page 104379]]

do not persist. Comments noted that composting practices are varied and 
diverse, especially between Agaricus and specialty mushroom producers, 
and questioned if the minimum requirements accommodate the variety of 
composting methods that mushroom producers may use to prepare compost. 
Relatedly, some comments requested clarification about how guidance 
documents related to heat-treated manure (NOP 5006) and alternative 
composting methods (NOP 5021) relate to this rule.
    (Response) The final rule maintains that composted plant and animal 
materials prepared for mushroom substrate must meet minimum 
requirements of maintaining a temperature of at least 131 [deg]F for at 
least three days. AMS recognizes that mushroom producers use a wide 
variety of processes to prepare substrate for mushroom production but 
is not aware of composting processes for mushrooms that do not achieve 
the minimum standard of 131 [deg]F for three days. Additionally, the 
final rule does not require producers to use compost. If a producer 
uses a process that does not meet the minimum temperature and time 
requirements of the final rule for compost, the agricultural materials 
must be organic, unless the material is not commercially available in 
organic form under Sec.  205.210(c)(2) or the input is a wood material 
meeting the requirements of Sec.  205.210(c)(3). Producers may continue 
to use a variety of processes, provided that the producer complies with 
the organic regulations and the minimum requirements for composted 
nonorganic plant and animal materials used in mushroom substrate.
Spawn
    (Comment) Several comments stated that spawn and spawn media 
requirements were not clearly distinguished from requirements for 
mushroom substrate or that the proposed rule included contradictory 
requirements for spawn. For example, comments questioned whether 
nonagricultural products or synthetic substances on the National List 
are allowed in organic spawn media.
    (Response) The final rule separates spawn and spawn media 
requirements from the requirements related to the mushroom substrate 
(substrate inoculated by spawn). This revision is intended to clearly 
distinguish the requirements for mushroom spawn media from the 
requirements for mushroom substrate. Paragraph 205.210(d) indicates 
that allowed synthetic substances and nonorganic wood materials may be 
added to spawn media and clarifies other composition requirements for 
organic spawn.
    (Comment) Some comments argued the rule should always require 
organic spawn media, without exception. Commenters argued that organic 
materials are available in sufficient quantity for organic spawn.
    Other commenters stated that there are not enough organic inputs to 
support organic spawn production. Specifically, a comment argued that 
there are not enough organic products to supply organic spawn at even a 
fraction of the total need. The comment noted that 750 to 850 million 
pounds of Agaricus mushrooms are produced annually in the United 
States, requiring hundreds of thousands of acres of straw and hay.
    (Response) AMS finds that there is likely sufficient organic spawn 
media to produce organic spawn in most cases. While 750 to 850 million 
pounds of Agaricus mushrooms are produced in the United States, less 
than 110 million pounds are produced organically.\22\ These organic 
mushrooms will use hundreds of millions of pounds of agricultural 
materials, mostly in their growing substrate (where composting and 
commercial availability provide flexibility for organic producers). 
Spawn materials make up less than five percent of the total need for 
agricultural materials in Agaricus production.\23\ The United States 
produced nearly 2.4 billion pounds of organic hay and straw in 2021, so 
AMS believes that there should be sufficient organic hay and straw for 
organic spawn production that requires these inputs.\24\
---------------------------------------------------------------------------

    \22\ USDA, National Agricultural Statistics Service, 
Agricultural Statistics Board. (August 21, 2024). ``Mushrooms.'' 
https://downloads.usda.library.cornell.edu/usda-esmis/files/r781wg03d/9593wm52z/9306vq05c/mush0824.pdf.
    \23\ PennState Extension. (March 6, 2023). ``Seeding Substate 
and Management of Growing Agaricus Bisporus.'' https://extension.psu.edu/seeding-substrate-and-management-of-growing-agaricus-bisporus.
    \24\ USDA, National Agricultural Statistics Service. (December 
2022). ``Certified Organic Survey 2021 Summary.'' https://www.nass.usda.gov/Publications/AgCensus/2022/index.php.
---------------------------------------------------------------------------

    However, AMS understands there may be limited circumstances when 
needed organic materials may not always be commercially available in 
all regions at all times of the year. Additionally, AMS understands 
that sawdust is often used as a spawn media and there are little to no 
organic wood products available. Because of this, the final rule 
maintains the proposed requirement that spawn must be organic when 
commercially available but provides limited exceptions for using 
nonorganic wood in organic spawn media and nonorganic spawn media when 
organic spawn and spawn media are not commercially available. This 
flexibility of the final rule will ensure that mushroom producers can 
consistently produce spawn to meet the needs of organic mushroom 
production.
    (Comment) A comment noted that spawn requirements did not clearly 
differentiate between the requirements for mushroom producers that only 
source spawn (from outside their operation) and producers that make 
their own spawn. Commenters questioned how commercial availability 
requirements (for sourcing spawn) apply to producers that make their 
own spawn on-site.
    (Response) AMS agrees that the rule should more fully consider 
those operations that not only source spawn but produce their own spawn 
for their mushroom production. The final rule more clearly describes 
spawn requirements for producers that make their own spawn (see Sec.  
205.210(d)(2)). The final rule clarifies that producers who produce 
their own spawn for their own mushroom production must use organic 
inputs for their spawn media, when commercially available. This 
revision will allow producers that make their own spawn to continue to 
do so but also clarifies that the same standard for organic 
agricultural uncomposted materials that applies to mushroom substrate 
also applies to spawn media. In the case that organic inputs are not 
used by a producer for spawn media when organic spawn is commercially 
available in the market, certifiers should pay close attention to 
claims that the spawn cannot be made to comply with organic spawn 
requirements.
    (Comment) Several comments from certifiers asked for clarification 
about how to review the ingredients in mycelium cultures used to 
inoculate spawn media (e.g., ingredients in agar plates) and whether 
those ingredients are subject to the same requirements as spawn and/or 
spawn media.
    (Response) The rule does not specify requirements for mycelium 
culture materials (e.g., ingredients in agar plates, liquid cultures, 
or slants). Organic mushroom spawn must be under continuous organic 
management after the mycelium is applied to the mushroom spawn media 
(Sec.  205.210(d)(1)(iii)). Other requirements for spawn and spawn 
media are described in Sec.  205.210(d).
Commercial Availability for Mushroom Spawn
    (Comment) A mushroom trade association stated the ``variety'' of 
spawn media was not relevant to

[[Page 104380]]

commercial availability searches, as proposed. The commenter states 
that the availability of specific spawn media may be impacted by 
factors even within a media variety (e.g., organic grain in one 
location may have different contaminants than the same grain grown in 
another location). Other commenters asked that the term ``variety'' be 
removed from the proposed regulatory text related to commercial 
availability as it is inconsistent with the existing regulatory 
definition of commercially available.
    (Response) AMS agrees that the emphasis on variety creates 
confusion with the commercial availability criteria. In this final 
rule, AMS has removed the proposed reference to ``variety'' in favor of 
functional equivalence for both spawn media and substrate. This change 
more clearly aligns with the definition of commercially available. This 
requirement may mean operations need to check the organic variety of a 
nonorganic input in many cases. Commercial availability allows for 
determinations based on quality of the product, which may include 
contaminants.
    (Comment) Some comments argued the rule should always require 
organic spawn, without exception. Comments argued that requiring 
organic spawn would support organic spawn producers. Some comments 
noted that removing any allowance for nonorganic spawn could also help 
assure consumers that organic mushrooms meet a consistent standard. 
Other comments acknowledged the need for a commercial availability 
exception for organic spawn. A mushroom trade association stated that 
many mushroom strains are proprietary, and if a given strain is not 
produced in organic form, it likely cannot be obtained or produced by 
any other source.
    (Response) A key goal of the final rule is to establish consistent 
standards for mushroom production, which includes the production of 
spawn and other related products. However, AMS disagrees with comments 
that argue organic spawn is available for all spawn production and 
should be required without any exceptions. AMS recognizes that organic 
spawn, especially for certain proprietary strains, may not be 
available. The final rule allows for use of nonorganic spawn when 
organic spawn is not commercially available. Producers will be able to 
continue using these strains if equivalent organic spawn is not 
commercially available.
``Ready-to-Use'' Products
    (Comment) Comments asked for clarification about how the standards 
apply to ``ready-to-use'' or ``ready-to-fruit'' mushroom logs, blocks, 
or kits, and whether a 2019 NOP memo to certifiers on the topic remains 
in effect. Comments noted that these products commonly contain 
nonorganic wood products (e.g., sawdust) as substrate, and questioned 
whether this would continue to be allowed under the final rule.
    (Response) This final rule replaces the 2019 memo from NOP to 
certifiers and continues to allow the use of nonorganic wood materials 
as mushroom substrate (Sec.  205.210(c)(3)). These products 
(collectively referred to here as ``RTU products'' or ``RTUs'') are 
sometimes marketed as ``ready-to-use spawn'' or ``spawn kits,'' but 
they can be generally described as mushroom substrate that has been 
inoculated with spawn and is readily able to produce harvestable 
mushrooms in situ with proper humidity and temperature control. In 
contrast, spawn does not contain substrate necessary to readily grow 
mushrooms and needs to be combined with substrate to produce a crop. As 
such, RTU products do not fall under the definition and description of 
``spawn'' in this final rule.
    Because RTU products contain both substrate and spawn, both must be 
produced and managed according to the applicable requirements of this 
final rule in order to produce organic mushrooms. Organic RTU mushroom 
production products must be produced by a certified organic operation 
in accordance with Sec.  205.210. The spawn used to inoculate the 
substrate must comply with Sec.  205.210(d). The substrate must comply 
with Sec.  205.210(c), which includes an allowance for nonorganic wood 
materials. This final rule ensures that RTU products must follow the 
same regulations as other inoculated mushroom substrate under Sec.  
205.210 for organic mushroom production.
Mycelial Biomass Ingredients
    (Comment) Comments asked AMS to change the standards or clarify how 
the standards apply to edible ``mycelial biomass'' used as an 
ingredient in food, beverages, supplements, and other processed 
products for direct human consumption. Comments also referred to these 
ingredients by other terms, such as ``mycelium biomass,'' ``mycomass,'' 
``full spectrum mycoproduct material,'' ``mycofermented mycelium,'' 
``mycofermented grain,'' or ``myceliated grain.'' Comments generally 
described these ingredients as being produced similarly to spawn, but 
with a longer growth time after the mycelium is applied to substrate. 
In general, a substrate material (e.g., grain, such as millet or rice) 
is inoculated with a culture and grown (or fermented) until nearly all 
the substrate is consumed by the mycelium and bio-converted into fungal 
tissue. The entire mycelial mass, including any un-converted substrate, 
may be dried or otherwise processed and used as an ingredient.
    (Response) AMS appreciates the detailed technical comments 
submitted about these ingredients (collectively referred to as 
``mycelial biomass'' in this response). AMS agrees with comments 
recognizing the differences between mycelial biomass used as an 
ingredient for direct human consumption, versus spawn used as a crop 
input to produce fruiting bodies which are then harvested for direct 
human consumption. AMS also recognizes that organic spawn meeting the 
requirements at Sec.  205.210(d)(1) for use as a crop input to produce 
organic mushrooms may not comply with the requirements for use as an 
ingredient in an organic processed product.
    AMS has not developed standards that are specific to mycelial 
biomass ingredients. However, this rule does not preclude or prevent 
the ongoing organic certification of mycelial biomass ingredients used 
in processed products. Ingredients used in organic processed products 
must follow the handling requirements in Sec.  205.270 and ingredient 
composition requirements in Sec.  205.301. Given that the substrate 
used to produce the mycelial biomass is included as part of the 
mycelial biomass ingredient in a processed product, the substrate must 
comply with the requirements at Sec.  205.301 for agricultural 
substances to be organic. Additionally, any non-agricultural or 
nonorganic ingredients must comply with applicable provisions of the 
National List of substances allowed in processed products (Sec. Sec.  
205.605 and 205.606). AMS understands, based on comments received on 
the proposed rule, that this reflects the current practice of 
certifiers that currently certify edible mycelial biomass ingredients 
for direct human consumption and other processed products that may 
contain these ingredients.
Exemptions
    (Comment) Some comments expressed a concern that exempting mushroom 
producers from certain crop production requirements could lead to other 
types of crop production systems

[[Page 104381]]

being allowed to avoid applicable regulations.
    (Response) This rule does not create or change the requirements for 
crop production other than mushrooms. Section 205.210 specifically 
recognizes the provisions of the organic crop standards that apply to 
organic mushroom production and establishes specific requirements that 
allow for the different production practices used to grow mushrooms. 
Establishing practice standards for other specialized crop production 
systems is outside the scope of this rule. This rule does not preclude 
future rulemaking regarding other types of specialized crop production 
systems.
    (Comment) A comment argued that mushroom producers should not be 
exempt from crop rotation requirements that apply to plant producers. 
They noted that rotation could support broad organic requirements to 
improve natural resources, support nutrient cycling, promote ecological 
balance, and conserve biodiversity.
    (Response) The rule does not require that mushroom producers rotate 
crops, or species of mushrooms, on their operations. Due to the nature 
of mushroom production, it is not clear how a mushroom producer would 
conduct crop rotations. Mushroom operations, however, must meet 
requirements at Sec.  205.200 to maintain or improve the natural 
resources of the operation, including soil and water quality. For these 
reasons, the final rule does not require mushroom operations to follow 
crop rotation standards at Sec.  205.205.
Sec.  205.601 (National List--Crop)
Description of Final Policy
    Section 205.105 of the organic regulations describes the allowed 
and prohibited substances in organic production and handling. That 
section states that synthetic substances may be used in organic 
production only if they are specifically included on the National List 
of allowed synthetic substances (Sec.  205.601).
    The final rule revises the definition of crop (Sec.  205.2) to 
clarify that mushrooms are a type of crop. This means that the National 
List for crop production is applicable to mushroom production.
    The final rule also updates the paragraph headings at Sec.  
205.601(i) and (j) to replace the term ``plant'' with ``crop'' in the 
phrases ``As plant disease control'' and ``As plant or soil 
amendments.'' These paragraphs describe the types of synthetic 
substances, grouped by function, that may be used in organic crop 
production. The revisions are intended to clarify that subsections 
205.601(i) and (j) of the National List, along with other substances 
for crop production listed throughout Sec.  205.601, are relevant for 
mushroom production.
    Substances used in mushroom production must also be used in 
accordance with any restrictions or annotations noted on the National 
List and only if permitted under applicable Federal and State laws and 
regulations. For example, the U.S. Environmental Protection Agency 
reviews pesticide product labels as part of the licensing/registration 
process and must approve the label language before a pesticide can be 
sold or distributed in the United States. It is a violation of Federal 
law to use a pesticide in a manner inconsistent with its labeling.
Changes From Proposed to Final Rule
    Following analysis of public comments, AMS has not made any changes 
to the proposed National List modifications in this final rule.
Responses to Public Comment
    Below is a summary of comments received regarding these changes to 
the National List (Sec.  205.601) and AMS's responses.
    (Comment) Some of the comments that argued for a new scope of 
certification for fungi (described earlier) also argued that AMS should 
create a new section of the National List for fungi inputs that is 
separate from the list for crop production in Sec.  205.601. Comments 
argued that substances on the National List for crop production do not 
apply to mushroom production, and those substances should be 
specifically petitioned for addition to the new section of the National 
List.
    (Response) AMS is not creating a separate section of the National 
List for fungi inputs, as requested, nor is AMS requiring inputs 
currently on the National List for use in crop production to be 
reviewed again for use in mushroom production. The crops section of the 
National List (Sec. Sec.  205.601 and 602) is already an established 
location for identifying mushroom production inputs, like the listing 
of microcrystalline cheesewax at Sec.  205.601(o)(2) for use in log 
grown mushroom production.
    Use of the crops section of the National List is also consistent 
with current practices of certifiers that certify mushrooms as a crop. 
These certifiers refer to the regulations and Sec.  205.105 and the 
crops section of the National List (Sec. Sec.  205.601 and 205.602) to 
determine allowed and prohibited materials for organic mushroom 
production. Furthermore, materials on the National List are subject to 
specific restrictions and annotation and may not be allowed for 
mushrooms. For these reasons, AMS does not view this as an expansion of 
allowable inputs, but rather, maintaining current practice. 
Stakeholders may refer to the National List Petition Guidelines for 
information on amending the National List.\25\
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    \25\ USDA, NOP. ``How to File a Petition.'' https://www.ams.usda.gov/rules-regulations/organic/national-list/filing-petition#NLpetitionGuidelines.
---------------------------------------------------------------------------

Responses to Public Comment on Implementation Timeline
    In the proposed rule, AMS specifically requested feedback about 
whether a one-year implementation period would be appropriate for the 
rule and what an appropriate implementation timeframe would be if one 
year was not appropriate. Comments on this topic as it related to the 
mushroom standards, and AMS's responses to comments, are discussed 
below.
    (Comment) Some comments argued that an extended implementation 
period would be needed if the final rule were to include specific 
changes they requested. For example, comments that requested AMS create 
a separate standard and scope of certification for all fungi also 
suggested that five years would be necessary for changes so sweeping. 
Others argued that a five-year implementation period would be adequate 
if the rule were to require that all mushroom substrate inputs be 
organic without exception.
    (Response) As previously discussed, AMS has declined to expand the 
standards to apply to all fungi or create a separate scope of 
certification for all fungal products, and AMS has retained an 
exception in the final rule for mushroom operations to use nonorganic 
inputs under specific conditions (see ``Responses to Public Comment'' 
in the above subsections labeled ``Sec.  205.2 (Terms defined)'' and 
``Sec.  205.210 (Mushroom production practice standards)''). As these 
changes were not adopted, a five-year implementation period is not 
necessary.
    (Comment) Some mushroom producers and a mushroom industry 
association stated that a one-year implementation period would be 
inadequate because there is not enough supply of organic agricultural 
or forestry byproduct to meet the demand.
    (Response) In response to these and other comments, the final rule 
allows nonorganic wood materials (i.e., sawdust, chips, logs, or other 
wood materials). Furthermore, it allows for nonorganic plant materials 
in

[[Page 104382]]

mushroom substrate when organic is not commercially available. For 
these reasons, AMS does not agree with the comment that the rule 
requires a long implementation period.
    However, in recognition of the changes in the final rule, AMS is 
providing a two-year implementation period to allow operations to 
update organic system plans, procedures, and recordkeeping systems to 
comply with the final rule.
    (Comment) Some commenters argued that a one-year implementation 
period would be too brief. Certifiers noted that one year does not 
allow enough time to notify operations of changes, collect updated 
organic system plan forms, and conduct inspections to the new 
requirements. Additionally, some certifiers said the recent 
Strengthening Organic Enforcement final rule is demanding certifier 
resources. These commenters requested a longer (e.g., two- to three-
year) implementation period for the rule.
    (Response) AMS is selecting an implementation approach for the 
final rule that recognizes time is required for certifiers and 
operations to understand the rule and then update forms, procedures, 
and recordkeeping systems. AMS believes that a two-year implementation 
period, for both the mushroom standards and the pet food standards, 
provides the regulatory certainty that the rule seeks to establish and 
will minimize business disruptions for organic operations and 
certifying agents.

IV. Organic Pet Food Standard

A. Pet Food Background

    This final rule regulates organic claims on pet food by amending 
the existing regulatory framework for processed organic products (Sec.  
205.270, Organic handling requirements) to clarify the composition and 
labeling requirements for organic pet food. These amendments allow 
organic pet food to be labeled and sold as ``100% organic,'' 
``organic,'' or ``made with organic (specified ingredients or food 
group(s)).'' The changes clarify that pet food is distinct from 
livestock feed, which has its own composition and labeling requirements 
(see Sec. Sec.  205.237 and 205.301(e)). This rule defines pet as ``Any 
domestic animal not used for the production and sale of food, fiber, or 
other agricultural-based consumer products.'' The rule defines pet food 
as ``Any commercial feed prepared and distributed for pet 
consumption.'' Throughout this rule, the term pet food is used to refer 
to all pet foods, including food for pets other than dogs and cats, 
unless otherwise noted. Feed for zoo animals falls outside the scope of 
this rule, as zoo animals are not domestic animals and do not fit the 
definition of pet.
    This rule regulates what organic pet food can contain and how 
organic claims may be used on pet food. Other aspects of the 
manufacturing, marketing, and sale of pet food--including its 
healthfulness and safety, nutritional value, and suitability for pets--
fall under the authority of the Food and Drug Administration (FDA) and 
State regulatory bodies. All pet food manufacturers, organic or 
otherwise, must comply with relevant Federal and State laws and 
regulations pertaining to pet food safety.
General Overview of U.S. Pet Food Regulations
    Pet food labels are regulated at the Federal and State levels. At 
the Federal level, FDA is responsible for overseeing and enacting the 
requirements of the Federal Food, Drug, and Cosmetic Act, which 
requires pet food to be safe, properly manufactured, and adequately 
labeled.\26\ FDA requires certain information on pet food labels: 
Proper identification of the product, a net quantity statement, the 
name and place of the manufacturer or distributor, and a proper listing 
of all ingredients.\27\ Some States enforce their own labeling 
regulations in addition to those administered by FDA. Most of these 
States follow versions of the Model Bill recommendations of the 
Association of American Feed Control Officials (AAFCO), an independent 
non-profit organization.\28\
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    \26\ FDA. (February 17, 2022). ``FDA's regulation of pet food.'' 
https://www.fda.gov/animal-veterinary/animal-health-literacy/fdas-regulation-pet-food.
    \27\ FDA. (February 3, 2023). ``Pet food.'' https://www.fda.gov/animal-veterinary/animal-food-feeds/pet-food. FDA's animal food 
labeling regulations are located at 21 CFR part 501.
    \28\ AAFCO. ``Labeling & labeling requirements.'' https://www.aafco.org/resources/startups/labeling-labeling-requirements/. 
Accessed May 1, 2023.
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    Pet food is often formulated as a complete nutrition product--i.e., 
the sole source of nourishment for pets. It typically contains 
ingredients from agricultural sources, minerals, vitamins or other 
nutrients, flavorings, preservatives, and processing aids to meet the 
nutrient requirements of the animal and the processing needs for the 
pet food.\29\ Many ingredients from agricultural sources such as meat, 
poultry, and grains are considered safe and do not require FDA's pre-
market approval. Other substances (including supplemental nutrients) do 
not require FDA's pre-market approval if they are on an FDA-maintained 
list of ingredients Generally Recognized as Safe (GRAS), otherwise they 
must have approval as food additives.\30\ The National Academy of 
Sciences' National Research Council (NRC) and AAFCO provide information 
on the nutrient requirements of dogs and cats at each stage of life 
(e.g., growth, reproduction, adult maintenance) to guide the 
formulation of nutritionally adequate pet foods. NRC has listed and 
described essential nutrients in its 2006 publication ``Nutrient 
Requirements of Dogs and Cats.'' \31\ On its website, AAFCO maintains 
more recently updated Nutrient Profiles for the various stages of life. 
The minimum nutrient levels specified in the AAFCO Nutrient Profiles 
are generally consistent with NRC Nutrient Requirement tables and are 
updated periodically as NRC recommendations change.
---------------------------------------------------------------------------

    \29\ FDA. (February 15, 2024). ``Pet Food.'' https://www.fda.gov/animal-veterinary/animal-food-feeds/pet-food.
    \30\ FDA. (August 4, 2023). ``Current animal GRAS notices 
inventory.'' https://www.fda.gov/animal-veterinary/generally-recognized-safe-gras-notification-program/current-animal-food-gras-notices-inventory.
    \31\ National Research Council. (2006). ``Nutrient requirements 
of dogs and cats.'' https://nap.nationalacademies.org/catalog/10668/nutrient-requirements-of-dogs-and-cats.
---------------------------------------------------------------------------

    This rule does not supersede the requirements of FDA or State 
regulatory bodies. Instead, this rule is intended to work jointly with 
those requirements and more narrowly regulate what manufacturers must 
do to label their pet food ``100% organic,'' ``organic,'' or ``made 
with organic (specified ingredients or food group(s)).'' Additionally, 
by including organic pet food in the organic regulations, the rule 
clarifies the process for adding substances to the National List 
specifically for use in organic pet food. Future amendments to the 
National List could be made, as necessary, in accordance with the 
process, requirements, and criteria described in OFPA (see 7 U.S.C. 
6517 and 6518).
Organic Pet Food Industry and Market
    Pet food is a large and growing market in the United States. 
According to recent data from the American Pet Products Association 
(APPA), roughly 82 million homes own a pet.\32\ Pet ownership increased 
during the COVID-19 pandemic when many people chose to adopt pets while 
working from home. According to an American Society for the Prevention 
of Cruelty to Animals

[[Page 104383]]

(ASPCA) survey, around 23 million homes (nearly one in five homes in 
the United States) adopted a cat or dog during the pandemic.\33\
---------------------------------------------------------------------------

    \32\ American Pet Products Association. ``Pet industry market 
size, trends & ownership statistics.'' Retrieved September 3, 2024. 
https://americanpetproducts.org/industry-trends-and-stats. Accessed 
September 3, 2024.
    \33\ ASPCA. ``New ASPCA survey: Vast majority of dogs and cats 
acquired during pandemic still in their homes.'' https://www.aspcapro.org/resource/new-aspca-survey-vast-majority-dogs-and-cats-acquired-during-pandemic-still-their-homes. Accessed September 
3, 2024.
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    In 2023, the pet food/treat market in the United States was valued 
at $64.4 billion and was projected to increase to $66.9 billion in 
2024.\34\ However, the organic pet food market remains small in 
comparison: as of 2021, the organic pet food market was less than one 
percent of the total pet food market.\35\ In 2023, sales of organic pet 
food dropped to $120 million, a decline of 7.4 percent from the 
previous year.\36\ The organic pet food market is relatively new, with 
few organic brands having been able to penetrate the market. AMS 
expects that as the number of organic options for pets increases, an 
untapped market of consumers may seek to purchase organic pet food for 
the same reasons that they purchase other organic foods.
---------------------------------------------------------------------------

    \34\ American Pet Products Association. ``Pet industry market 
size, trends & ownership statistics.'' https://americanpetproducts.org/industry-trends-and-stats. Accessed 
September 3, 2024.
    \35\ Organic Trade Association. (2022). Organic Industry Survey. 
p. 108.
    \36\ Organic Trade Association. (2024). Organic Industry Survey. 
p. 74.
---------------------------------------------------------------------------

B. Need for Organic Pet Food Standards

    The lack of specific standards for organic pet food has created 
inconsistency and uncertainty around labeling and composition 
requirements for organic pet food. Certifiers have used various 
combinations of the standards for livestock feed and processed 
products, neither of which are entirely sufficient. The handling 
standards are appropriate for verifying the processing, handling, 
product composition, and labeling requirements for multi-ingredient 
processed agricultural products, but they lack specific allowances for 
nutrients that are necessary for pets. Conversely, the livestock feed 
standards include allowances for many of the nutrients that are 
necessary for pets, but they prohibit common pet food ingredients, such 
as slaughter by-products.
    These regulatory gaps have increased the risk for businesses in the 
organic pet food market, hindered production innovation, and limited 
the market for organic slaughter by-products. This rule addresses these 
inconsistencies and creates clearer regulatory standards specifically 
for slaughter by-products and nutrients in organic pet food.
Organic Slaughter By-Products
    The term ``organic slaughter by-products'' refers to the parts of 
an organic animal, managed and slaughtered according to the organic 
regulations, that humans do not typically eat, such as offal, gristle, 
and bone. These by-products come from organically managed animals, but 
livestock producers do not often receive organic premiums for them due 
to an insufficient market for organically produced slaughter by-
products.
    Section 205.237(b)(5) prohibits feeding slaughter by-products to 
mammals or poultry. This is a necessary precaution for livestock raised 
as food for human consumption; however, slaughter by-products are a 
commonly used protein source in pet food. In the past, some certifying 
agents have used the composition requirements for organic livestock 
feed (Sec.  205.301(e)) to certify pet food as organic, but livestock 
feed produced under the organic standards may not sufficiently address 
the nutritional needs of pets. Some certifying agents have allowed 
organic slaughter by-products in pet food, while other certifiers have 
not. These contradictions create uncertainty for businesses that 
currently produce organic pet food and are a barrier to businesses that 
would like to start producing organic pet food or selling slaughter by-
products to the organic pet food market.
    Slaughter by-products make up approximately 23 percent of the 
composition of conventional pet food, in part to meet protein levels 
required by Federal and State regulations.\37\ AMS estimates that there 
are currently over 12 million pounds of organic meat and organic 
slaughter by-products used in pet food annually. Prior to the 
publication of this final rule, it was unclear if pet food 
manufacturers could use meat or slaughter by-products in organic pet 
food. This uncertainty has likely limited the growth of the organic pet 
food market. By clarifying that these products can be used in organic 
pet food, this rule could broaden the market and increase demand for 
those organic livestock products. Based on feedback from stakeholders, 
AMS finds it likely that organic meat and slaughter by-product demand 
will grow over time beyond this estimate after implementation of this 
rule.
---------------------------------------------------------------------------

    \37\ Institute for Feed Education & Research. (March 2020). 
``Pet food production and ingredient analysis.''
---------------------------------------------------------------------------

Vitamins, Minerals, and Amino Acids
    Most dry and wet pet foods are multi-ingredient products, as 
multiple ingredients are needed to meet the nutritional needs of a pet. 
The product that forms the largest share of the pet food market is 
kibble,\38\ or dry ``complete and balanced'' \39\ pet food, which is 
intended to supply a pet's daily nutritional needs of essential 
vitamins, minerals, and amino acids.
---------------------------------------------------------------------------

    \38\ Kibble accounted for 62.8 percent of all pet food sales in 
2020. Pet Food Processing. (December 1, 2020). ``State of the US pet 
food and treat industry, 2020.'' https://www.petfoodprocessing.net/articles/14294-state-of-the-us-pet-food-and-treat-industry-2020.
    \39\ FDA. (February 28, 2020). ``Complete and Balanced Pet 
Food.'' https://www.fda.gov/animal-veterinary/animal-health-literacy/complete-and-balanced-pet-food.
---------------------------------------------------------------------------

    Prior to the publication of this rule, there has been uncertainty 
about which nutrients are allowed in organic pet food. Some certifying 
agents have used the composition requirements for organic livestock 
feed (Sec.  205.301(e)) to identify allowable nutrients in organic pet 
food. Those standards allow the use of FDA-approved vitamins and 
minerals that appear on the National List of allowed substances for 
livestock production (Sec.  205.603(d)(2) and (3)), many of which are 
commonly used in pet foods. Other certifiers have used the handling 
standards in Sec.  205.270, which allow nutrient vitamins and minerals 
that appear on the National List of allowed substances for processing/
handling at Sec. Sec.  205.605 and 205.606. However, these standards do 
not explicitly allow the vitamin and mineral ingredients that appear on 
the National List for livestock production at Sec.  205.603(d), which 
may also be important for pet food. Neither the livestock production 
nor the processing/handling lists of allowed synthetic nutrient 
vitamins and minerals is sufficient to address the range of essential 
nutrients for pet food.
    Furthermore, neither section of the National List allows for 
certain synthetic amino acids, such as taurine, that are commonly used 
in pet food. Taurine is a synthetic amino sulfonic acid that is a 
necessary part of a healthy diet for many pets (all cats and some dog 
breeds). For that reason, AAFCO's cat nutrient profiles require 
taurine, and it is a common synthetic additive in pet foods for other 
pets. Taurine is essential for pet health and adequate taurine levels 
cannot always be achieved using organic agricultural ingredients alone. 
The natural form of taurine is present in raw meat but not in processed 
pet food in its final form, as taurine is destroyed by heat, which is 
applied during pet food processing to comply with pet food

[[Page 104384]]

safety standards.\40\ To compensate for this loss, pet food 
manufacturers often add synthetic forms of taurine to certain pet 
foods. As synthetic taurine was previously not approved for organic pet 
food, some certifiers limited the types of pet food that could be 
certified as organic to single-ingredient treats. This limited the 
growth of the overall organic pet food market.
---------------------------------------------------------------------------

    \40\ Spitze, A.R., Wong, D.L., Rogers, Q.R., & Fascetti, A.J. 
(2003). ``Taurine concentrations in animal feed ingredients; cooking 
influences taurine content.'' Journal of Animal Physiology and 
Animal Nutrition, 87(7-8), 251-262. https://pubmed.ncbi.nlm.nih.gov/12864905/.
---------------------------------------------------------------------------

Final Rule Response
    This final rule resolves these problems by, first, establishing 
that organic pet food is regulated as a processed product rather than 
as livestock feed. This allows organic pet food to include slaughter 
by-products from certified organic animals, which remain under 
continuous organic management through the slaughter process. This 
clarification creates consistency between certifying agents, removes 
uncertainty for pet food manufacturers, and expands the market for 
organic livestock producers who sell slaughter by-products. Allowing 
slaughter by-products in organic pet food will likely increase demand 
for certified organic slaughter by-products and create additional 
income streams for organic livestock producers and meat processors. AMS 
expects that the changes brought about by this final rule will 
encourage additional growth in the small organic pet food market and 
other latent organic markets that support it, such as the market(s) for 
organic slaughter by-products.
    Second, this final rule clarifies the vitamins, minerals, and amino 
acids that are allowed as ingredients in organic pet food to ensure 
that pet food manufactures can formulate pet foods that meet the daily 
nutritional needs of pets. It permits the use of the vitamin and 
mineral feed additives referenced in Sec. Sec.  205.603(d)(2) and (3) 
in pet food, and it adds taurine to the National List at Sec.  
205.605(b) as an allowed nonorganic ingredient in organic pet food. 
Revising the organic regulations to clearly allow the essential 
nutrients required in pet food will allow companies to produce multi-
ingredient dry and wet pet food products that are certified organic and 
meet the complete nutritional needs of pets.
    Third, this rule regulates pet food under the existing composition 
and labeling requirements for processed products referenced in Sec.  
205.270 rather than under the requirements for livestock feed. This 
allows producers to make the organic labeling claims: ``100 percent 
organic,'' ``organic,'' or ``made with organic (specified ingredient or 
food group(s)).'' These labeling claims are regulated under the USDA 
organic regulations (Sec. Sec.  205.301, 205.303, and 205.304) and are 
used extensively by certified organic handlers. ``100 percent organic'' 
is used to label any product with 100 percent organic ingredients, 
``organic'' products must contain at least 95 percent organic 
ingredients, and ``made with organic'' products must contain at least 
70 percent organic ingredients. The regulations established in this 
final rule also permit the identification of organically produced 
ingredients in the ingredient statement of certain products (Sec. Sec.  
205.301(d) and 205.305). In the first three cases, any nonorganic 
ingredient(s) must also meet specific criteria.\41\
---------------------------------------------------------------------------

    \41\ USDA, AMS. (April 2018). ``Organic Labels Explained.'' 
https://www.ams.usda.gov/sites/default/files/media/OrganicLabelsExplained.png.
---------------------------------------------------------------------------

    By clarifying that pet food can be labeled with the various organic 
claims described above, the rule provides pet food manufacturers with 
the flexibility to make and market a range of products that contain 
organic ingredients. In turn, AMS expects the rule could increase the 
availability of organic products for consumers and bolster markets for 
organic ingredients by increasing demand.
    In conclusion, this rule addresses inconsistencies in how 
certifying agents are applying the current organic regulations to pet 
food. It also resolves regulatory uncertainties that artificially 
increase risk in the organic pet food market. Addressing these 
inconsistencies and uncertainties should create the conditions 
necessary for organic pet food and related markets to grow.

C. Overview of Final Rule Policy and Responses to Comments

    This final rule amends the USDA organic regulations (7 CFR part 
205) by defining ``pet'' and ``pet food'' in the regulations and adding 
a new paragraph for pet food in Sec.  205.270, organic handling 
requirements. This action integrates organic pet food standards into 
existing USDA organic labeling categories for agricultural products 
(subpart D of part 205) and specifies the ingredients that can be 
included in pet food labeled ``100 percent organic,'' ``organic,'' 
``made with organic (specified ingredients or food group(s)),'' or in 
products with less than 70 percent organic ingredients (ingredient list 
claims only). Table 2 summarizes the amendments to the USDA organic 
regulations that add pet food composition and labeling standards.

 Table 2--Overview of Regulatory Changes To Establish Pet Food Standards
------------------------------------------------------------------------
        Section title             Type of action      Rulemaking action
------------------------------------------------------------------------
205.2........................  Adds new terms......  Defines terms pet
                                                      and pet food.
205.270......................  Adds new paragraph..  Adds composition
                                                      and labeling
                                                      requirements
                                                      specific to pet
                                                      food.
205.605(b)...................  Adds substance to     Adds taurine to the
                                the National List.    National List as
                                                      an allowed
                                                      ingredient in pet
                                                      food.
------------------------------------------------------------------------

Sec.  205.2 (Terms Defined)
Description of Final Policy
    The final rule amends Sec.  205.2 by adding two new terms, pet and 
pet food.
1. Pet
    The rule defines pet as ``any domestic animal not used for the 
production and sale of food, fiber, or other agricultural-based 
consumer products.'' This term establishes a distinction between 
animals raised as pets and animals raised for food or fiber (i.e., 
``livestock,'' as defined at Sec.  205.2). Animals used for food or in 
the production of food, fiber, feed, or other agricultural-based 
consumer products are ``livestock'' under the USDA organic regulations 
(Sec.  205.2) and must be produced under all applicable organic 
livestock requirements. Feed requirements for organic livestock are 
described at Sec.  205.237 and do not apply to organic pet food, and 
vice versa.
2. Pet Food
    The rule defines pet food as ``any commercial feed prepared and 
distributed for pet consumption.'' The definition for pet food 
distinguishes organic pet food products from organic livestock feed 
products. This action is

[[Page 104385]]

consistent with the NOSB's recommendation.\42\ It also addresses 
concerns from pet food manufacturers that applying livestock feed 
composition requirements to pet food could limit product formulation 
and participation in the organic market due to the lack of available 
organic protein sources, especially rendered products like poultry 
meal. Unless otherwise noted, the term pet food refers to all pet 
foods, including food for pets other than dogs and cats. Feed for zoo 
animals is not included in the definition, as zoo animals are not 
domestic animals and therefore fall outside the definition of pets.
---------------------------------------------------------------------------

    \42\ NOSB. (November 19, 2008). ``Formal recommendation by the 
National Organic Standards Board (NOSB) to the National Organic 
Program (NOP): Organic pet food standards recommendation.'' https://www.ams.usda.gov/sites/default/files/media/NOP%20Final%20Rec%20Pet%20Food.pdf.
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Changes From Proposed to Final Rule
    Following analysis of public comments, AMS has not made any changes 
to the proposed definitions of pet and pet food in this final rule. See 
the following section for a more detailed discussion of public comments 
on these definitions and AMS's response to those comments.
Responses to Public Comment
    Below is a summary of comments received regarding organic pet food 
definitions and AMS's responses.
    (Comment) Some commenters, including AAFCO, requested that AMS 
align its definitions with the AAFCO Model Bill and State feed laws. 
AAFCO suggested that the proposed definition of pet should be changed 
to align with the Model Bill which defines a pet as a dog or a cat 
only. AAFCO also suggested that AMS consider additional definitions for 
specialty pet (``any animal normally maintained in a household, such 
as, but not limited to, rodents, ornamental birds, ornamental fish, 
reptiles, amphibians, ferrets, hedgehogs, marsupials, and rabbits not 
raised for food or fur'' and specialty pet food (``any commercial feed 
prepared and distributed for consumption by specialty pets''). In 
contrast, other commenters, including a feed industry association and 
several organic certifying agencies, supported AMS's definitions for 
pet and pet food, stating that the definitions are clear and would work 
well within the existing regulatory frameworks for pet food.
    (Response) AMS acknowledges and appreciates AAFCO's work developing 
industry standards. However, AMS has chosen not to modify or add to the 
proposed definitions of pet or pet food in this final rule. AMS 
acknowledges that the definition of pet in this rule is broader than 
AAFCO's definition, but this rule regulates organic food for all types 
of pets equally and does not present unique requirements for different 
categories of pets or specialty pets. Without any differences in 
labeling or composition requirements for different types of pets in 
this rule, AMS does not find it necessary to distinguish between types 
of pets and prefers to use a single and inclusive term (pet) for all 
types of pets. Importantly, this rule does not change a manufacturer's 
obligations to comply with Federal or State requirements that may have 
different requirements for pet food and specialty pet food. AMS's 
decision to use a broad and inclusive definition of pet in this rule 
ensures that the organic regulations are flexible to accommodate any 
other detailed Federal and State requirements for pet food and specific 
types of pets.
    (Comment) Some comments questioned AMS's definition of pet food as 
a type of ``commercial feed . . . for pet consumption.'' These comments 
stated that standards for ``food'' products and ingredients are higher 
than standards for ``feed'' products and ingredients, with differences 
in quality and safety standards. They argued that defining pet food as 
a type of feed would confuse consumers about whether organic pet food 
was human grade.
    (Response) The final rule does not revise the definition of pet 
food, as we do not believe that the market expects the term pet food to 
mean a product meets human grade food standards. Therefore, we do not 
expect that the term will mislead consumers. For the purposes of the 
organic regulations, AMS finds that the broad and common term pet food 
is most appropriate. See additional discussion of comments related to 
human grade standards for pet food in section ``Sec.  205.270 (Organic 
handling requirements)'' below.
Sec.  205.270 (Organic Handling Requirements)
Description of Final Policy
    This final rule adds a new paragraph (d) to Sec.  205.270--organic 
handling requirements--to describe requirements for the composition, 
processing, and labeling of organic pet food. New paragraph (d) 
specifies the types of processing aids and ingredients that are allowed 
in organic pet food. By including pet food as part of the organic 
handling requirements in Sec.  205.270, and therefore clearly 
separating pet food standards from the livestock feed composition and 
labeling standards, the rule ensures that pet food is not subject to 
the prohibition on the use of slaughter by-products that exists for 
livestock feed. The rule allows slaughter by-products in pet food under 
the same composition and labeling requirements for other multi-
ingredient products described at Sec.  205.301(a) through (d) and (f). 
The term organic slaughter by-products refers to the parts of organic 
animals that humans do not typically eat, such as offal, gristle, and 
bone. It does not refer to substandard animal products from diseased 
animals, uninspected animals, condemned animals, or animals deemed 
unfit for human consumption.
    The final rule (Sec.  205.270(d)) permits organic pet food, like 
other processed organic products regulated under Sec.  205.270, to 
contain nonorganic substances allowed by the National List in Sec.  
205.605 (such as taurine, as finalized by this rule) and Sec.  205.606. 
These ingredients may be used in processed pet food products labeled as 
``organic'' or ``made with organic (specified ingredients or food 
group(s)),'' in accordance with Sec.  205.301(b) and (c), respectively. 
Additionally, the rule allows the feed additive vitamins and minerals 
in Sec.  205.603(d)(2) and (3) to also be used for enrichment or 
fortification of pet food.
    Paragraph 205.270(d) also clarifies that pet food with organic 
claims must be labeled pursuant to subpart D of the organic 
regulations. For instance, organic pet food must be labeled according 
to the product composition requirements at Sec.  205.301(a) through (d) 
and (f). In addition, pet food may use the following labeling 
categories: (a) ``100 percent organic;'' (b) ``organic,'' (c) ``made 
with organic (specified ingredients or food group(s));'' or (d) 
products containing less than 70 percent organic ingredients (organic 
ingredients identified on the ingredient statement only). This action, 
in combination with the new definition for pet food, as distinct from 
livestock feed, allows the labeling of organic pet food using the same 
framework as multi-ingredient processed food products (rather than the 
requirements for livestock feed). The requirements for livestock feed 
composition (Sec.  205.301(e)) and livestock feed labeling (Sec.  
205.306) do not apply to pet food.
    The changes to Sec.  205.270 do not replace or modify requirements 
pertaining to pet food that are applicable under other Federal or State 
laws or regulations. This rule regulates only the organic claims on pet 
food. All other aspects of pet food formulation,

[[Page 104386]]

production, labeling, and sale must follow the relevant Federal and 
State laws and regulations.
Changes From Proposed to Final Rule
    Following analysis of public comments, AMS has not made any 
substantive changes to the proposed organic handling requirements in 
this final rule. The final rule adds pet food requirements at Sec.  
205.270(d) rather than Sec.  205.270(c), as proposed, to minimize 
impacts related to documents and policies that currently reference the 
requirements at Sec.  205.270(c). The final rule also removes 
references to ``the applicable portions of'' Subpart D, as proposed, in 
favor of a clear and direct reference to Subpart D. AMS expects all 
operations, including pet food manufacturers, to comply with the 
applicable portions of Subpart D that are relevant to the product types 
and claims of the certified product. This rule clarifies that livestock 
feed composition and labeling are not applicable to pet food.
Responses to Public Comment
    Below is a summary of comments received regarding organic pet food 
handling requirements and AMS's responses.
    (Comment) Several thousand commenters, responding to a mass comment 
campaign initiated by an organic advocacy group, requested that AMS 
ensure that organic pet food, including any livestock products used as 
ingredients in pet food, meet ``human grade'' food standards.
    (Response) This final rule does not require the use of ``human 
grade'' standards for organic pet food or its ingredients. All organic 
livestock products are subject to the organic regulations, as well as 
other State and Federal regulations that may apply. AMS understands 
that other organizations, including AAFCO, have defined ``human grade'' 
and/or have recommended detailed guidelines for use of the ``human 
grade'' claim on pet food. For example, under the ``human grade'' 
guidelines recommended by AAFCO, each ingredient must be stored, 
handled, processed, and transported under human food laws and 
regulations, and facilities must be registered with the FDA as a human 
food and animal food facility, among other requirements. Adopting such 
standards in the final rule would go well beyond the scope of the 
proposed requirements. However, nothing in this rule prevents organic 
pet food operations from additionally making truthful ``human grade'' 
claims on organic pet food products.
    (Comment) The mass comment campaign noted above also requested that 
no fallen or condemned animals (or portions of animals) or animals that 
die by means other than slaughter be allowed in organic pet food. Some 
other individual commenters echoed these requests, requesting that AMS 
require USDA inspection of slaughtered animals or facilities 
slaughtering animals to ensure no condemned animals are used in pet 
food.
    (Response) AMS agrees with the commenters that organic pet food 
must not contain condemned, diseased, or otherwise unsanitary animal 
products, and the final rule should in no way be misconstrued to permit 
them. AMS has not revised the final rule to address these topics 
because AMS did not propose specific language on this topic and because 
other laws and regulations, including organic regulations, exist that 
address these issues. Under the current regulations, organic slaughter 
facilities must be certified organic and are subject to annual on-site 
inspections from their certifier. The organic regulations specifically 
prohibit seriously crippled and non-ambulatory animals from being sold 
or slaughtered as organic (Sec.  205.242(a)(2)).
    Additionally, organic regulations require that organic livestock be 
slaughtered in compliance with USDA Food Safety Inspection Service 
(FSIS) regulations, FSIS Directives, and other laws (Sec.  205.242(b) 
and (c)). The FSIS regulations (e.g., 9 CFR part 309 and part 314) 
include specific regulations related to handling condemned (e.g., 
diseased) animals/or animal parts. They also include regulations 
related to animals that have died other than by slaughter (i.e., dead 
animals) and diseased, dying, and disabled animals.
    Finally, AMS is not including a requirement for USDA inspection of 
slaughter plants associated with organic slaughter for pet food. Not 
all animals in the United States are slaughtered at USDA-inspected 
facilities. For example, some facilities are inspected by States only. 
Therefore, AMS is not including a requirement that slaughter facilities 
be USDA-inspected; however, organic facilities, including slaughter 
facilities, are still subject to annual on-site inspections by their 
organic certifier.
    (Comment) Several commenters asked for clarification about how 
vitamins and minerals listed in Sec. Sec.  205.603(d)(2) and (3) should 
be reviewed for use in organic pet food. Commenters asked about whether 
AAFCO-approved vitamins and minerals would be allowed, and other 
questions related to the applicability of NOP Guidance 5030, 
``Evaluating Allowed Ingredients and Sources of Vitamins and Minerals 
for Organic Livestock Feed''.
    (Response) The final rule permits the vitamin and mineral feed 
additives referenced in Sec.  205.603(d)(2) and (3), which include 
vitamins and minerals that are FDA approved. AMS defers to applicable 
FDA regulations and guidance in determining which specific substances 
are FDA approved.\43\ Section 4.2.3 of NOP Guidance 5030, ``Evaluating 
Allowed Ingredients and Sources of Vitamins and Minerals for Organic 
Livestock Feed,'' contains additional information to help determine 
whether certain vitamins or minerals are allowed under Sec.  
205.603(d)(2) and (3). For the purpose of determining compliance for 
organic pet food, if the vitamin or mineral is allowed under Sec.  
205.603(d)(2) or (3), then it is also allowed for use in organic pet 
food.
---------------------------------------------------------------------------

    \43\ FDA has recently announced that it would not renew its MOU 
with AAFCO and review its procedures for reviewing animal food 
ingredients. To assist with the transition, FDA has released two 
draft Guidance for Industry documents:
    FDA. (August 2024). ``CVM GFI #293--FDA Enforcement Policy for 
AAFCO-Defined Animal Feed Ingredients.'' https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-293-fda-enforcement-policy-aafco-defined-animal-feed-ingredients.
    FDA. (August 2024). ``CVM GFI #294--Animal Food Ingredient 
Consultation (AFIC).'' https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-294-animal-food-ingredient-consultation-afic.
---------------------------------------------------------------------------

Sec.  205.605 (National List)
Description of Final Policy
    The final rule modifies the National List to allow the use of 
synthetic taurine in pet food. The rule adds taurine to Sec.  205.605, 
which describes nonorganic nonagricultural substances allowed as 
ingredients in or on processed products labeled as ``organic'' or 
``made with organic (specified ingredients or food group(s)).'' The 
amendment for taurine also specifies that taurine can be used only in 
pet food and not in other organic multi-ingredient products.
    This addition implements an NOSB recommendation to add taurine to 
the National List as an allowed substance for use exclusively in pet 
foods. AMS agrees with NOSB's rationale and recommendation. As 
described above, taurine is essential for pet health and adequate 
taurine levels cannot always be achieved using organic agricultural 
ingredients alone.
Changes From Proposed to Final Rule
    Following analysis of public comments, AMS has not made any changes 
to the proposed National List modifications (Sec.  205.605) in this 
final rule.

[[Page 104387]]

Responses to Public Comment
    Below is a summary of comments received regarding organic pet food 
National List standards and AMS's responses.
    (Comment) One commenter, a pet food trade association, argued that 
the rule should allow for the use of a broader range of amino acids in 
organic pet food, rather than allowing taurine only. They suggested 
replacing the proposed rule's addition of taurine to the National List 
with the statement ``Amino acids, used for enrichment or fortification 
when FDA-approved for use only in pet food.''
    (Response) AMS understands the potential need for other amino acids 
in pet food production apart from taurine. However, taurine is a common 
synthetic additive in pet food that is vital nutrition for all cat 
breeds (and some dog breeds) and cannot be obtained in adequate amounts 
from pet food that does not include synthetic taurine. This decision 
follows NOSB's recommendation to add only taurine to the National List. 
NOSB has not recommended other animo acids for use in organic pet food. 
Therefore, this rule only includes the addition of taurine to the 
National List.
    Individuals may petition to add other substances to the National 
List for use in organic pet food, following the National List Petition 
Guidelines.\44\ Because organic pet food must meet all applicable 
Federal and State laws and regulations, any person or organization 
petitioning to add a substance to the National List for use in organic 
pet food must ensure the use of that substance is consistent with 
applicable Federal and State laws and rules. Synthetic substances 
petitioned for use in pet food will be evaluated according to the 
existing criteria in OFPA (7 U.S.C. 6517 and 6518) and the USDA organic 
regulations (7 CFR 205.600).
---------------------------------------------------------------------------

    \44\ USDA, NOP. How to File a Petition. https://www.ams.usda.gov/rules-regulations/organic/national-list/filing-petition#NLpetitionGuidelines.
---------------------------------------------------------------------------

    (Comment) Some commenters claimed that it is not necessary to 
include taurine on the National List because it exists naturally in 
foods such as eggs, red algae, and meats. Additionally, some commenters 
asked if taurine should be allowed in all pet food or just cat food, 
because cats need additional taurine in food whereas dogs are able to 
physiologically synthesize taurine by consuming foods containing the 
amino acids cysteine and methionine. Other commenters requested that 
taurine should be included as an allowed substance specifically for 
cats and dogs, rather than for pets generally.
    (Response) In 2013, the NOSB Livestock Subcommittee proposed adding 
taurine to the National List as an allowed substance for use 
exclusively in pet foods to meet nutritional requirements for cats. 
After public comments argued that taurine can also be necessary for 
dogs' nutrition, NOSB issued its final recommendation for taurine to be 
allowed in pet food generally. AMS agrees with NOSB's rationale and 
recommendation on the basis that taurine is essential for pet health 
and that synthetic taurine must be added to pet food, in certain cases, 
to reach the levels that are necessary for pet health.
Responses to Public Comment on Implementation Timeline
    AMS requested feedback about whether a one-year implementation 
period would be appropriate for the rule. Comments that are 
specifically related to the pet food standards implementation, and 
AMS's responses to comments, are discussed below.
    (Comment) Some commenters stated that an extended implementation 
period is not necessary for the pet food portion of the rule, as the 
rule does not restrict operations compared to current practices. A 
commenter noted that certifiers already use the framework described in 
the proposed rule for the certification of pet food. Commenters noted 
that if the final rule adopted the proposed rule as-is, a one-year 
implementation timeline would be sufficient.
    (Response) AMS agrees that pet food operations will not need to 
make any major changes to comply with the final rule. In fact, by 
allowing the use of taurine (an amino acid) in organic pet food, the 
final rule is less restrictive than existing standards. However, AMS is 
providing a two-year implementation period for the final rule, 
including the pet food requirements, to allow operations and certifying 
agents time to understand the rule and update forms and inspection 
procedures to reflect the final rule.
    AMS notes that operations are not restricted from complying with 
the final rule prior to the compliance date. For example, pet food 
operations may use taurine in organic pet food starting on the 
effective date of the final rule.

V. Regulatory Analyses

Executive Orders 12866, 13563, 14094, and the Regulatory Flexibility 
Act

    This rule does not meet the criteria of a ``significant regulatory 
action'' under Executive Order 12866, as supplemented by Executive 
Order 13563 and updated by Executive Order 14094. Therefore, the Office 
of Management and Budget (OMB) has not reviewed this rule under those 
orders.
    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) requires 
agencies to consider the economic impact of each rule on ``small 
entities'' and evaluate alternatives that would accomplish the 
objectives of the rule without unduly burdening small entities or 
erecting barriers that would restrict their ability to compete in the 
market. The purpose of the RFA is to fit regulatory actions to the 
scale of businesses subject to the action. Section 605(b) of the RFA 
allows an agency to certify that a rule will not have a significant 
economic impact on a substantial number of small entities instead of 
preparing a regulatory flexibility analysis, provided that the agency 
sets forth the factual basis for such certification. AMS has concluded 
and hereby certifies that this rule will not have a significant 
economic impact on a substantial number of small entities; therefore, 
an analysis is not included. Below, AMS presents information about the 
industry and the possible effects of the rule on small entities to 
support this conclusion.
    The Small Business Administration (SBA) sets size criteria for each 
industry described in the North American Industry Classification System 
(NAICS) to delineate which operations qualify as small businesses. 
SBA's size standards are expressed in terms of number of employees or 
annual receipts and indicate the maximum allowed for an entity to be 
considered small.\45\
---------------------------------------------------------------------------

    \45\ U.S. SBA. (March 17, 2023). Table of size standards. 
https://www.sba.gov/document/support-table-size-standards.
---------------------------------------------------------------------------

    Mushroom Producers. AMS has considered the economic impact of this 
rulemaking on small mushroom producers. At the time of this analysis, 
small organic mushroom producers were listed under NAICS code 111411 
(Mushroom Production) as grossing equal to or less than $4,500,000 per 
year.\46\ AMS estimates that out of 239 domestic operations reporting 
sales of organic mushrooms, approximately 4 operations exceed that 
threshold.\47\

[[Page 104388]]

While most organic mushroom operations that would be affected by this 
rule are small entities, this rule only has the potential to impose 
minor costs on them related to paperwork burden (see ``Paperwork 
Reduction Act'' section below) and costs associated with sourcing 
organic spawn and substrate materials, when commercially available. AMS 
concludes that this rule will not have a significant economic impact on 
a substantial number of these small entities.
---------------------------------------------------------------------------

    \46\ U.S. SBA. (March 17, 2023). Table of size standards. 
https://www.sba.gov/document/support-table-size-standards.
    \47\ The National Agricultural Statistics Service was unable to 
supply a precise tabulation of large organic operations due to 
disclosure concerns. AMS estimated the number of large mushroom 
operations and sales from large mushroom operations using the 
proportion of conventional mushroom operations by sales from the 
USDA's 2022 Census of Agriculture, available here: https://www.nass.usda.gov/Publications/AgCensus/2022/index.php. The same 
distribution is assumed to apply to organic mushroom operations.
---------------------------------------------------------------------------

    Pet Food Operations. AMS has considered the economic impact of this 
rulemaking on small organic pet food producers. At the time of this 
analysis, small organic pet food producers were listed under NAICS code 
311111 (Dog and Cat Food Manufacturing) as employing equal to or fewer 
than 1,250 employees.\48\ AMS estimates that given the small size of 
the organic pet food market, most of the 29 domestic organic pet food 
operations are small entities. Pet food operations may incur small one-
time paperwork costs (see ``Paperwork Reduction Act'' section below), 
but the rule establishes standards for organic pet food handling that 
align with many existing industry practices. Additionally, the rule 
allows operations to use additional inputs (e.g., taurine) in organic 
pet food, which provides pet food operations more production options 
without additional costs. AMS concludes that this rule will not have a 
significant economic impact on a substantial number of these small 
entities.
---------------------------------------------------------------------------

    \48\ U.S. SBA. (March 17, 2023). Table of size standards. 
https://www.sba.gov/document/support-table-size-standards.
---------------------------------------------------------------------------

    Certifying agents. This final rule also affects certifying agents 
that certify organic mushroom or pet food operations. At the time of 
this analysis, the SBA defined small agricultural service firms, which 
include certifying agents, as those having annual receipts equal to or 
less than $19,500,000 (NAICS code 541990--All Other Professional, 
Scientific and Technical Services). There are currently 73 USDA-
accredited certifying agents, and AMS believes most of these certifying 
agents are small entities. Certifying agents must already comply with 
existing regulations and already certify these operations. Certifying 
agents may incur minor one-time paperwork costs (see ``Paperwork 
Reduction Act'' section below). However, this rule reduces the current 
burden of creating and maintaining certifier-level policies for the 
certification of organic mushroom production and organic pet food 
handling. AMS concludes that this rule will not have a significant 
economic impact on a substantial number of these small entities.

Executive Order 12988

    Executive Order 12988 instructs each executive agency to adhere to 
certain requirements in the development of new and revised regulations 
to avoid unduly burdening the court system. This rule complies with 
these requirements. This rule cannot be applied retroactively. 
Additionally, to prevent duplicative regulation, States and local 
jurisdictions are preempted under OFPA from creating accreditation 
programs for private persons or State officials who want to become 
certifying agents of organic farms or handling operations. A governing 
State official would have to apply to USDA to be accredited as a 
certifying agent, as described in OFPA (7 U.S.C. 6514(b)). States are 
also preempted under sections 6503 through 6507 of OFPA from creating 
certification programs to certify organic farms or handling operations 
unless the State programs have been submitted to, and approved by, the 
Secretary as meeting the requirements of OFPA.
    Pursuant to section 6507(b)(2) of OFPA, a State organic 
certification program that has been approved by the Secretary may, 
under certain circumstances, contain additional requirements for the 
production and handling of agricultural products organically produced 
in the State and for the certification of organic farm and handling 
operations located within the State. Such additional requirements must 
(a) further the purposes of OFPA, (b) not be inconsistent with OFPA, 
(c) not be discriminatory toward agricultural commodities organically 
produced in other States, and (d) not be effective until approved by 
the Secretary.
    In addition, pursuant to section 6519(c)(6) of OFPA, this 
rulemaking does not supersede or alter the authority of the Secretary 
under the Federal Meat Inspection Act (21 U.S.C. 601-624), the Poultry 
Products Inspection Act (21 U.S.C. 451-471), or the Egg Products 
Inspection Act (21 U.S.C. 1031-1056), concerning meat, poultry, and egg 
products, respectively, nor any of the authorities of the Secretary of 
Health and Human Services under the Federal Food, Drug and Cosmetic Act 
(21 U.S.C. 301-399i), nor the authority of the Administrator of the 
Environmental Protection Agency under the Federal Insecticide, 
Fungicide and Rodenticide Act (7 U.S.C. 136-136y).
    OFPA at 7 U.S.C. 6520 provides for the Secretary to establish an 
expedited administrative appeals procedure under which persons may 
appeal an action of the Secretary, the applicable governing State 
official, or a certifying agent under the statute that adversely 
affects such person or is inconsistent with the organic certification 
program established under OFPA. OFPA also provides that the U.S. 
District Court for the district in which a person is located has 
jurisdiction to review the Secretary's decision.

Executive Order 13132

    Executive Order 13132 mandates that Federal agencies consider how 
their policymaking and regulatory activities impact the policymaking 
discretion of States and local officials and how well such efforts 
conform to the principles of federalism defined in said order. This 
executive order pertains only to regulations with clear federalism 
implications.
    AMS has determined that this rulemaking conforms with the 
principles of federalism described in E.O. 13132. The rule does not 
impose substantial direct costs or effects on States, does not alter 
the relationship between States and the Federal government, and does 
not alter the distribution of powers and responsibilities among the 
various levels of government. States had the opportunity to comment on 
any potential federalism implications during the proposed rule's 
comment period. No States provided public comment on the federalism 
implications of this rule. Therefore, AMS has concluded that this 
rulemaking does not have federalism implications.

Executive Order 13175

    Executive Order 13175 requires Federal agencies to consult and 
coordinate with Tribes on a government-to-government basis on policies 
that have Tribal implications, including regulations, legislative 
comments, or proposed legislation. Additionally, other policy 
statements or actions that have substantial direct effects on one or 
more Indian Tribes, the relationship between the Federal Government and 
Indian Tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian Tribes also require 
consultation. After consultation with the USDA Office of Tribal 
Relations, AMS determined that a Tribal consultation for this 
rulemaking was not necessary, as it was unlikely to impact Tribes. If a 
Tribe requests consultation in the future, AMS will work with the

[[Page 104389]]

Office of Tribal Relations to ensure meaningful consultation is 
provided.

Civil Rights Impact Analysis

    AMS has reviewed this rulemaking in accordance with the 
Departmental Regulation 4300-4, Civil Rights Impact Analysis, to 
address any major civil rights impacts the rule might have on 
minorities, women, and/or persons with disabilities. After a careful 
review of the rule's intent and provisions, AMS determined there is no 
evidence that this final rule will have adverse civil rights impacts on 
organic producers identifying as minorities, women, and/or persons with 
disabilities. Additionally, this final rule does not impose any 
requirements related to eligibility for benefits and services on 
protected classes, nor does the rule have the purpose or effect of 
treating classes of persons differently.
    Protected individuals have the same opportunity to participate in 
NOP as non-protected individuals. USDA organic regulations prohibit 
discrimination by certifying agents. Specifically, 7 CFR 205.501(d) of 
the current regulations for accreditation of certifying agents provides 
that ``No private or governmental entity accredited as a certifying 
agent under this subpart shall exclude from participation in or deny 
the benefits of the National Organic Program to any person due to 
discrimination because of race, color, national origin, gender, 
religion, age, disability, political beliefs, sexual orientation, or 
marital or family status.'' Paragraph 205.501(a)(2) requires certifying 
agents to ``[d]emonstrate the ability to fully comply with the 
requirements for accreditation set forth in this subpart,'' including 
the prohibition on discrimination. The granting of accreditation to 
certifying agents under Sec.  205.506 requires the review of 
information submitted by the certifying agent and an on-site review of 
the certifying agent's client operation. Further, if certification is 
denied, Sec.  205.405(d) requires that the certifying agent notify the 
applicant of their right to file an appeal to the AMS Administrator in 
accordance with Sec.  205.681.
    These regulations provide protections against discrimination, 
thereby permitting all producers, regardless of race, color, national 
origin, gender, religion, age, disability, political beliefs, sexual 
orientation, or marital or family status, who voluntarily choose to 
adhere to the rules and qualify, to be certified as meeting NOP 
requirements by an accredited certifying agent. This action in no way 
changes any of these protections against discrimination.

Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3521) (PRA), AMS is requesting OMB approval for a new information 
collection totaling 2,371 hours for the reporting and recordkeeping 
requirements contained in this final rule. OMB previously approved 
information collection requests (ICR) associated with the NOP and 
assigned OMB control number 0581-0191. AMS intends to merge this new 
information collection, upon OMB approval, into the previously approved 
collection request (OMB control number 0581-0191). Below, AMS describes 
and estimates the annual burden (i.e., the amount of time and cost of 
labor) for entities to prepare and maintain information to participate 
in the voluntary labeling program. OFPA, as amended, provides authority 
for this action.
    Title: National Organic Program: Market Development for Mushrooms 
and Pet Food.
    OMB Control Number: 0581-0347.
    Expiration Date of Approval: Three years from OMB date of approval.
    Type of Request: New collection.
Abstract
    Information collection is necessary to implement the reporting 
requirements for organic mushroom production and pet food handling 
under the USDA organic regulations (7 CFR 205.210 and 205.270). This 
final rule establishes USDA organic requirements in the mushroom and 
pet food sectors to support consistent interpretation and remove 
regulatory uncertainty. By doing so, it supports the purposes of OFPA, 
namely, ``to establish national standards'' for products marketed as 
organic and ``to assure consumers that organically produced products 
meet a consistent standard.'' (7 U.S.C. 6501). Additional information 
on the purpose and need for this rule is included in the BACKGROUND 
section of this rule.
Overview
    Information collection and recordkeeping will be required to 
demonstrate compliance with new provisions in Sec.  205.210 and 
amendments to Sec.  205.270 of the USDA organic regulations, 7 CFR part 
205, that establish standards for mushroom production and pet food 
handling. These amendments will require one-time additional reporting 
for already certified pet food and mushroom operations, accredited 
certifying agents, and inspectors. Existing organic mushroom and pet 
food operations will need to read the rule and review their organic 
system plans (OSPs) for compliance. Certifiers will have to read the 
rule and review the updated plans, and certifiers and inspectors will 
require training on the new regulation.
    Additionally, the final rule adds allowances for nonorganic plant 
materials to be used in mushroom substrate when functionally equivalent 
organic materials are not commercially available. This allowance will 
require additional documentation for organic mushroom operations. AMS 
is estimating that organic mushroom operations will have annual 
reporting and recordkeeping paperwork burdens to utilize this 
exception. The estimates have been updated to reflect this change.
Burden Estimates
    This burden estimate accounts for certified organic mushroom 
operations and certified organic pet food operations updating OSPs, 
mushroom operations verifying and keeping records of commercial 
availability exceptions for organic substrate, certifiers reviewing 
updated OSPs, and certifiers training inspectors to comply with the 
final rule.
    Number of Respondents: 519.
    Frequency of Response: One time only and annual (for mushroom 
operations).
    Annual Hour Burden: 2,371 total hours; 1,219 one-time hours; 1,152 
annual hours.
    The 519 respondents include 322 certified organic operations (288 
mushroom operations and 34 pet food operations), 56 certifying agents, 
and 141 inspectors.

                                         Table 3--Total Paperwork Burden
----------------------------------------------------------------------------------------------------------------
                                                Total number of                         Total
            Total reporting burden                 reporting     Total reporting    recordkeeping     Total all
                                                  respondents       hours--all       hours--all         costs
----------------------------------------------------------------------------------------------------------------
Summary of Tables 4, 5, & 6...................             519            1,795               576   $121,696.63
----------------------------------------------------------------------------------------------------------------


[[Page 104390]]

Certified Organic Operations
    AMS estimates that 322 certified organic mushroom and organic pet 
food operations may need to update their OSPs to comply with the final 
rule.\49\
---------------------------------------------------------------------------

    \49\ USDA. Organic Integrity Database. https://organic.ams.usda.gov/IntegrityPlus/Search.aspx. To obtain the 
relevant data, search for ``mushroom'' and ``pet, dog, canine, cat, 
feline'' in the ``Certified Products'' field. Accessed August 27, 
2024.
---------------------------------------------------------------------------

    AMS estimates that each certified organic mushroom and pet food 
operation will require one response of two reporting hours to read the 
rule and update their OSPs. AMS estimates that each respondent will 
require no additional recordkeeping hours, as these operations already 
have and store OSPs. This results in a total one-time hour burden of 
644 hours for certified organic mushroom and pet food operations across 
322 responses.
    Because the rule allows organic mushroom operations to use 
nonorganic plant inputs in mushroom substrate if an organic input of a 
similar function is not commercially available, the operation must 
verify and record if organic inputs of similar function are not 
commercially available. AMS estimates that each operation will need to 
verify and document inputs approximately two times a year. Each 
verification will require one response of one reporting hour and one 
recordkeeping hour. This results in a total annual hour burden of 1,152 
hours for certified organic mushroom operations across 576 responses. 
See table 4 below for a summary of these estimates for certified 
organic operations.

                                      Table 4--Certified Organic Operations
----------------------------------------------------------------------------------------------------------------
                                                    Wage \50\ \51\ +     Total          Total
        Respondent categories           Number of     benefits \52\    reporting    recordkeeping    Total costs
                                       respondents        \53\           hours          hours
----------------------------------------------------------------------------------------------------------------
USDA Certified Mushroom Producers &            268            $56.22          536                0       $30,134
 Pet Food Handlers--Domestic (One-
 time)..............................
USDA Certified Mushroom Producers &             54             42.22          108                0         4,560
 Pet Food Handlers--Foreign (One-
 time)..............................
USDA Certified Mushroom Producers--            239             56.22          478              478        53,746
 Domestic (Annual--Commercial
 Availability)......................
USDA Certified Mushroom Producers--             49             42.22           98               98         8,275
 Foreign (Annual--Commercial
 Availability)......................
                                     ---------------------------------------------------------------------------
    USDA Organic Operations--All....           322  ................        1,220              576        96,715
----------------------------------------------------------------------------------------------------------------

Certifying Agents
    AMS estimates that 56 certifying agents will need to review 322 
OSPs from certified organic mushroom and pet food operations.
---------------------------------------------------------------------------

    \50\ Domestic hourly wage rates are based on the National 
Compensation Survey: Occupational Employment and Wages, May 2023, 
published by the Bureau of Labor Statistics. Bureau of Labor 
Statistics. ``May 2023 National Occupational Employment and Wage 
Estimates.'' https://www.bls.gov/oes/current/oes_nat.htm. Accessed 
August 27, 2024.
    \51\ International wage rates are estimated based on the 
proportional average of World Bank GDP per capita rates for 
Organization for Economic Co-Operation and Development (OECD) 
countries compared to the U.S. (72.2%). World Bank. ``GDP per 
capita, PPP (current international $).'' https://data.worldbank.org/indicator/NY.GDP.PCAP.PP.CD. Accessed August 27, 2024.
    \52\ Domestic benefit rates are based on data from Bureau of 
Labor Statistics News Release on Employer Costs for Employee 
Compensation. Wages account for 70.3% and Benefits account for 29.7% 
of total average employer compensation costs. Bureau of Labor 
Statistics. (June 18, 2024). ``Employer Costs for Employee 
Compensation Summary.'' https://www.bls.gov/news.release/ecec.nr0.htm. Accessed August 27, 2024.
    \53\ International benefit rates are based on an average tax 
wedge of OECD countries (34.9% of wage rates). OECD. ``OECD 
comparative indicators.'' https://stats.oecd.org/Index.aspx?DataSetCode=AWCOMP. Accessed August 27, 2024.
---------------------------------------------------------------------------

    AMS estimates that on average, certifying agents will require one 
response of one reporting hour to review OSPs for each organic mushroom 
and pet food operation they certify, resulting in a total of 322 hours 
over 322 responses. Additionally, AMS estimates each certifying agent 
will require one response of two hours to read the rule and provide 
training to staff and inspectors on the new requirements. AMS estimates 
that these are one-time burdens and each respondent requires no 
additional reporting/recordkeeping hours as these operations already 
review and store OSPs (the burden to review and store these is captured 
under the existing ICR, OMB control number 0581-0191). This results in 
a total one-time hour burden of 434 hours for certifying agents across 
378 responses. See table 5 below for a summary of the estimates for 
certifying agents.

[[Page 104391]]



                                           Table 5--Certifying Agents
----------------------------------------------------------------------------------------------------------------
                                                                     Wage \54\ \55\ +     Total
                Respondent categories                    Number of     benefits \56\    reporting    Total costs
                                                        respondents        \57\           hours
----------------------------------------------------------------------------------------------------------------
USDA U.S.-Based Certifiers--Mushrooms................            32            $50.00          303       $15,150
USDA Foreign-Based Certifiers--Mushrooms.............            10             37.54           69         2,590
USDA U.S.-Based Certifiers--Pet food.................            10             50.00           49         2,450
USDA Foreign-Based Certifiers--Pet food..............             4             37.54           13           488
                                                      ----------------------------------------------------------
    USDA Certifiers--All.............................       \58\ 56  ................          434        20,678
----------------------------------------------------------------------------------------------------------------

Inspectors 
---------------------------------------------------------------------------

    \54\ Domestic hourly wage rates are based on the National 
Compensation Survey: Occupational Employment and Wages, May 2023, 
published by the Bureau of Labor Statistics. Bureau of Labor 
Statistics. ``May 2023 National Occupational Employment and Wage 
Estimates.'' https://www.bls.gov/oes/current/oes_nat.htm. Accessed 
August 27, 2024.
    \55\ International wage rates are estimated based on the 
proportional average of World Bank GDP per capita rates for 
Organization for Economic Co-Operation and Development (OECD) 
countries compared to the U.S. (72.2%). World Bank. ``GDP per 
capita, PPP (current international $).'' https://data.worldbank.org/indicator/NY.GDP.PCAP.PP.CD. Accessed August 27, 2024.
    \56\ Domestic benefit rates are based on data from Bureau of 
Labor Statistics News Release on Employer Costs for Employee 
Compensation. Wages account for 70.3% and Benefits account for 29.7% 
of total average employer compensation costs. Bureau of Labor 
Statistics. (June 18, 2024). ``Employer Costs for Employee 
Compensation Summary.'' https://www.bls.gov/news.release/ecec.nr0.htm. Accessed August 27, 2024.
    \57\ International benefit rates are based on an average tax 
wedge of OECD countries (34.9% of wage rates). OECD. ``OECD 
comparative indicators.'' https://stats.oecd.org/Index.aspx?DataSetCode=AWCOMP. Accessed August 27, 2024.
    \58\ Some certifiers may certify both pet food and mushroom 
operations but are counted as separate entities in this column.
---------------------------------------------------------------------------

    AMS estimates that 141 organic inspectors will need to receive 
training on the final rule.\59\
    AMS estimates that each organic inspector will require one response 
of one reporting hour to receive training on the final rule. AMS 
estimates that each respondent will require no additional recordkeeping 
hours. This results in a total annual hour burden of 141 hours for 
organic inspectors across 141 responses. See table 6 below for a 
summary of these estimates for inspectors.
---------------------------------------------------------------------------

    \59\ This estimate is based on data from the International 
Organic Inspectors Association (IOIA) Membership Directory, 
available at https://www.ioia.net/member-directory. Based on 
adjustments due to public comment (see ``Comments,'' below), AMS 
estimates that half of inspectors are present in the IOIA Membership 
Directory and adjusts the number of inspectors receiving training 
proportionally by the percentage of certifiers certifying organic 
mushroom or pet food operations.
    \60\ Domestic hourly wage rates are based on the National 
Compensation Survey: Occupational Employment and Wages, May 2023, 
published by the Bureau of Labor Statistics. Bureau of Labor 
Statistics. ``May 2023 National Occupational Employment and Wage 
Estimates.'' https://www.bls.gov/oes/current/oes_nat.htm. Accessed 
August 27, 2024.
    \61\ International wage rates are estimated based on the 
proportional average of World Bank GDP per capita rates for 
Organization for Economic Co-Operation and Development (OECD) 
countries compared to the U.S. (72.2%). World Bank. ``GDP per 
capita, PPP (current international $).'' https://data.worldbank.org/indicator/NY.GDP.PCAP.PP.CD. Accessed August 27, 2024.
    \62\ Domestic benefit rates are based on data from Bureau of 
Labor Statistics News Release on Employer Costs for Employee 
Compensation. Wages account for 70.3% and Benefits account for 29.7% 
of total average employer compensation costs. Bureau of Labor 
Statistics. (June 18, 2024). ``Employer Costs for Employee 
Compensation Summary.'' https://www.bls.gov/news.release/ecec.nr0.htm. Accessed August 27, 2024.
    \63\ International benefit rates are based on an average tax 
wedge of OECD countries (34.9% of wage rates). OECD. ``OECD 
comparative indicators.'' https://stats.oecd.org/Index.aspx?DataSetCode=AWCOMP. Accessed August 27, 2024.

                                               Table 6--Inspectors
----------------------------------------------------------------------------------------------------------------
                                                                       Wage 60 61 +       Total
                Respondent categories                    Number of    benefits 62 63    reporting    Total costs
                                                        respondents                       hours
----------------------------------------------------------------------------------------------------------------
USDA U.S.-based Inspectors...........................           106            $32.53          106        $3,448
USDA Foreign based Inspectors........................            35            $24.43           35           855
                                                      ----------------------------------------------------------
    USDA Inspectors--All.............................           141  ................          141         4,303
----------------------------------------------------------------------------------------------------------------

Comments
    AMS published a proposed rule and request for public comment in the 
Federal Register on March 11, 2024 (89 FR 17322). The 60-day notice 
regarding paperwork impacts is embedded in the proposed rule and 
provides stakeholders an opportunity to comment on the accuracy of the 
information collection request. The 60-day comment period ended on May 
10, 2024. AMS asked four specific information collection request 
questions in the proposed rule:
    1. Whether the proposed collection of information is necessary for 
the proper performance of the functions of the agency, including 
whether the information would have practical utility.
    2. The accuracy of the agency's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used.
    3. Ways to enhance the quality, utility, and clarity of the 
information to be collected.
    4. Ways to minimize the burden of the collection of information on 
those who are to respond, including the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology.
    During the comment period, AMS received two comments (discussed 
below) that provided feedback on the initial paperwork burden of the 
rule.
    (Comment) A comment stated that the number of inspectors estimated 
by AMS in the proposed rule's paperwork burden was too low because the 
directory of inspectors from the International Organic Inspectors 
Association does not include non-

[[Page 104392]]

members or members that do not wish to share their information. 
Additionally, the comment stated that the estimated wages were too low.
    (Response) AMS has adjusted the estimated number of total 
inspectors based on this comment. Absent specific data, we assume that 
the IOIA database contains half (50 percent) of all inspectors, 
changing our total number from 185 inspectors present in the IOIA 
database as of August 27, 2024, to 370 inspectors. AMS acknowledges 
that without specific input this estimate may be imprecise. To further 
account for this adjustment and acknowledge that not all inspectors 
will inspect the 288 mushroom or pet food facilities, AMS adjusted the 
percentage of inspectors impacted by the paperwork costs to be 
proportional to the percentage of certifiers that certify operations 
for mushroom production or pet food handling.
    AMS did not adjust the source for hourly wages in the burden 
estimates for the final rule. AMS acknowledges that costs may be higher 
for inspectors in some areas. However, without comprehensive data from 
another source, AMS believes that the Bureau of Labor Statistics 
estimates for wages remain the most accurate estimates for wages to use 
in burden estimates.
    (Comment) One comment argues the requirement in Sec.  205.210(b) 
that mushroom operations manage substrate in such a way to avoid 
environmental contamination may be duplicative with Sec.  205.203(c), 
given that both would seem to apply to mushroom operations. On the 
other hand, another comment states that reiterating the requirement for 
mushroom operations is critical.
    (Response) Paragraph 205.210(b) specifically adds requirements that 
operations must prevent mushroom substrate and spawn media from 
contaminating crops, spawn, mushroom substrate, soil, or water. AMS 
acknowledges that this is similar to Sec.  205.203(c). However, the 
regulatory text at Sec.  205.210(a) specifies the crop requirements 
applicable to organic mushroom production and specifically excludes 
Sec.  205.203(c) to prevent duplicative requirements. AMS is not 
adjusting these requirements and finds them to be necessary and non-
duplicative.

List of Subjects in 7 CFR Part 205

    Administrative practice and procedure, Agricultural commodities, 
Agriculture, Animals, Archives and records, Fees, Imports, Labeling, 
Livestock, Organically produced products, Plants, Reporting and 
recordkeeping requirements, Seals and insignia, Soil conservation.


    For the reasons set forth in the preamble, the Agricultural 
Marketing Service amends 7 CFR part 205 as follows:

PART 205--NATIONAL ORGANIC PROGRAM

0
1. The authority citation for 7 CFR part 205 continues to read as 
follows:

    Authority:  7 U.S.C. 6501-6524.


0
2. Amend Sec.  205.2 by:
0
a. Revising the definitions of ``Compost'' and ``Crop'';
0
b. Adding in alphabetical order definitions for ``Mushroom'', 
``Mushroom Mycelium'', ``Mushroom spawn'', ``Mushroom spawn media'', 
``Mushroom substrate'', ``Pet'', and ``Pet food''; and
0
c. Revising the definition of ``Wild crop''.
    The revisions and additions read as follows:


Sec.  205.2  Terms defined.

* * * * *
    Compost. The product of a managed process through which 
microorganisms break down plant and animal materials into more 
available forms suitable for application to the soil or as a component 
of mushroom substrate.
* * * * *
    Crop. Pastures, cover crops, green manure crops, catch crops, 
mushrooms, or any plant or part of a plant intended to be marketed as 
an agricultural product, fed to livestock, or used in the field to 
manage nutrients and soil fertility.
* * * * *
    Mushroom. The fleshy, spore-bearing fruiting body of a fungus.
    Mushroom mycelium. A mass of branching, thread-like hyphae (fungal 
structures).
    Mushroom spawn. Mushroom spawn media colonized by mushroom mycelium 
that can be used to inoculate mushroom substrate.
    Mushroom spawn media. The base material, such as grain, wood 
materials, or minerals, used to make mushroom spawn.
    Mushroom substrate. The base material, such as grain, wood 
materials, composted materials, and/or other agricultural materials, on 
which mushroom production occurs.
* * * * *
    Pet. Any domestic animal not used for the production and sale of 
food, fiber, or other agricultural-based consumer products.
    Pet food. Any commercial feed prepared and distributed for pet 
consumption.
* * * * *
    Wild crop. Any mushroom, plant, or portion of a plant that is 
collected or harvested from a site that is not maintained under 
cultivation or other agricultural management.
* * * * *

0
3. Add Sec.  205.210 to read as follows:


Sec.  205.210  Mushroom production practice standard.

    (a) The producer must manage mushroom production in accordance with 
the provisions of Sec. Sec.  205.200, 205.201, 205.202 as applicable, 
205.203(e), and 205.206(a)(2) and (3) and (b) through (f). The producer 
may manage crop nutrients for mushroom production in accordance with 
the provisions of Sec.  205.203(d).
    (b) The producer must manage mushroom substrate and mushroom spawn 
media, including spent mushroom substrate and mushroom spawn media, in 
a manner that does not contribute to contamination of crops, mushroom 
spawn, mushroom substrate, soil, or water by pathogenic organisms, 
heavy metals, or residues of prohibited substances.
    (c) Mushroom substrate may be composed of the following materials 
in accordance with the conditions specified in this paragraph:
    (1) Composted plant and animal materials. Compost used in mushroom 
substrate must be described in the organic system plan. It must be 
produced through a process that maintains a temperature of at least 131 
[deg]F for at least three days;
    (2) Uncomposted plant materials. Uncomposted plant materials must 
be organically produced: Except, that, nonorganically produced 
uncomposted plant materials may be used when a functionally equivalent 
organically produced material is not commercially available. Prohibited 
substances must not be applied to nonorganically produced uncomposted 
plant materials after harvest. Operations that use nonorganically 
produced uncomposted plant materials in mushroom substrate (except for 
wood materials allowed under paragraph (c)(3) of this section) must 
describe in the organic system plan:
    (i) The procedures used to search for organic materials and the 
records kept to document searches;
    (ii) The criteria used to evaluate if functionally equivalent 
organic materials are commercially available; and

[[Page 104393]]

    (iii) The recordkeeping system used to document purchases of 
nonorganic materials, including a summary of the type(s) and total 
amount of each nonorganic material used in mushroom substrate.
    (3) Wood chips, sawdust, logs, or other materials derived from wood 
that have not been treated with a prohibited substance after harvest;
    (4) Nonsynthetic substances, except those on the National List of 
nonsynthetic substances prohibited for use in organic crop production 
(Sec.  205.602); and
    (5) Synthetic substances on the National List of synthetic 
substances allowed for use in organic crop production (Sec.  205.601).
    (d) Mushroom spawn must be organic: Except, that, nonorganic 
mushroom spawn may be used to produce an organic crop when an 
equivalent organic mushroom spawn is not commercially available.
    (1) Organic mushroom spawn requirements.
    (i) Agricultural materials used as mushroom spawn media must be 
organic: Except, that, nonorganic wood materials in compliance with 
paragraph (c)(3) of this section are allowed.
    (ii) Mushroom spawn media may contain materials allowed in mushroom 
substrate at paragraphs (c)(1), (4), and (5) of this section.
    (iii) Organic mushroom spawn must be under continuous organic 
management after the mycelium is applied to the mushroom spawn media.
    (2) Organic mushroom operations that produce their own mushroom 
spawn for their own organic mushroom production must use organic 
agricultural materials for mushroom spawn media, unless a functionally 
equivalent organic agricultural material is not commercially available: 
Except that, wood materials in compliance with paragraph (c)(3) of this 
section are allowed.


0
4. Amend Sec.  205.270 by adding paragraph (d) to read as follows:


Sec.  205.270  Organic handling requirements.

* * * * *
    (d) In addition to the substances described in paragraph (b) of 
this section, substances allowed under Sec.  205.603(d)(2) and (3) may 
be used in or on pet food intended to be sold, labeled, or represented 
as ``organic'' or ``made with organic (specified ingredients or food 
group(s)),'' pursuant to Sec.  205.301(b) and (c). Pet food must be 
labeled pursuant to subpart D of this part.


0
5. Amend Sec.  205.601 by revising paragraphs (i) introductory text and 
(j) introductory text to read as follows:


Sec.  205.601  Synthetic substances allowed for use in organic crop 
production.

* * * * *
    (i) As crop disease control.
* * * * *
    (j) As crop or soil amendments.
* * * * *

0
6. Amend Sec.  205.605 by redesignating paragraphs (b)(36) and (37) as 
paragraphs (b)(37) and (38), respectively and adding new paragraph 
(b)(36) to read as follows:


Sec.  205.605  Nonagricultural (nonorganic) substances allowed as 
ingredients in or on processed products labeled as ``organic'' or 
``made with organic (specified ingredients or food group(s)).''

* * * * *
    (b) * * *
    (36) Taurine--for use only in pet food.
* * * * *

Erin Morris,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2024-30211 Filed 12-20-24; 8:45 am]
BILLING CODE P`